Sigma Chemical Co.

Medical device manufacturer in St. Louis, MO.

231510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K933694Sigma Glucose ReagentCGA · Traditional 11/04/1994SE
K933678Sigma Calcium ReagentCJY · Traditional 03/11/1994SE
K933696Sigma Electrolyte Reference ReagentJFL · Traditional 01/03/1994SE
K933691Sigma CO2 Alkaline Buffer ReagentJFL · Traditional 12/17/1993SE
K933679Sigma Bun ReagentLFP · Traditional 12/17/1993SE
K933703Sigma Wash Concentrate SolutionJJE · Traditional 12/10/1993SE
K933692Sigma CO2 Acid ReagentJFL · Traditional 12/09/1993SE
K933695Sigma Electrolyte BufferJFL · Traditional 10/22/1993SE
K933697Sigma Cre ReagentCGX · Traditional 10/18/1993SE
K933693Sigma CX-3 Calibration Standard Level 2JIX · Traditional 10/13/1993SE
K933702Sigma CX-3 Calibration Standard Level 1JIX · Traditional 10/08/1993SE
K930050Sia Thyroid Stimulating Hormone Elisa KitJLW · Traditional 08/19/1993SE
K901189Monoclonal Antibody ANTI-CD3GKZ · Traditional 10/31/1991SE
K901188Monoclonal Antibody ANTI-CD5GKZ · Traditional 10/31/1991SE
K901187Monoclonal Antibody ANTI-CD2GKZ · Traditional 10/31/1991SE
K901186Monoclonal Antibody ANTI-CD19GKZ · Traditional 10/31/1991SE
K904022Nitro Blue Tetrazolium ReductionGHD · Traditional 12/18/1990SE
K903995Naphthol As-D Chlor/A-Naphthyl Acet Esterase KitGHD · Traditional 12/13/1990SE
K904341Aptt ReagentGFO · Traditional 11/08/1990SE
K902098Cholesterol (Rate) ReagentCHH · Traditional 08/09/1990SE
K902363Coagulation Control, Level IIIGGN · Traditional 07/26/1990SE
K902362Coagulation Control, Level IIGGN · Traditional 07/26/1990SE
K902361Coagulation Control, Level IGGN · Traditional 07/26/1990SE
K902294Accuscan Microbead StandardsJIW · Traditional 07/03/1990SE
K902096Thromboplastin with CalciumGJS · Traditional 07/03/1990SE
K901675Apolipoprotein A-I (Apo A-I)DEL · Traditional 04/26/1990SE
K900906Factor II Deficient PlasmaGJT · Traditional 03/06/1990SE
K900412Factor Xii Deficient PlasmaGJT · Traditional 03/06/1990SE
K900411Factor Xi Deficient PlasmaGJT · Traditional 03/06/1990SE
K900410Factor X Deficient PlasmaGJT · Traditional 03/06/1990SE
K900409Factor Ix Deficient PlasmaGJT · Traditional 03/06/1990SE
K900408Factor Viii Deficient PlasmaGJT · Traditional 03/06/1990SE
K900407Factor Vii Deficient PlasmaGJT · Traditional 03/06/1990SE
K900406Factor V Deficient PlasmaGJT · Traditional 03/06/1990SE
K900124Apolipoprotein B (Apo B)DEL · Traditional 03/02/1990SE
K896258CO2 Reagent (340 NM)KHS · Traditional 02/13/1990SE
K896650Amylase ReagentJFJ · Traditional 02/08/1990SE
K896545Activated Partial Thromboplastin Time (Aptt)GFO · Traditional 12/01/1989SE
K896092Alkaline Phosphatase, Leukocyte, KitGHD · Traditional 11/09/1989SE
K894467Thrombin Time ReagentGJA · Traditional 09/05/1989SE
K893560Alt Reagent (Procedure Number 159)CKA · Traditional 07/20/1989SE
K893416Uric Acid Reagent (Procedure Number 686)KNK · Traditional 06/23/1989SE
K892844Ast Reagent (Procedure Number 158)CIT · Traditional 06/20/1989SE
K885272Cholinesterase Reagent, Dibucaine & FluorideDIH · Traditional 03/28/1989SE
K890278Total Protein ReagentCEK · Traditional 03/09/1989SE
K884574Dme & Ham's Nutrient Mixture, Prod. No. D9785KIT · Traditional 11/22/1988SE
K884573HBSS W/O Calc Chlor/Mag Sulf/Phen Red/Sb No. H4891KIT · Traditional 11/22/1988SE
K884572RPMI-1640 Hybri-Max, Prod. No. R5382KIT · Traditional 11/22/1988SE
K883972Magnesium Reagent (Magon Sulfonate)JGJ · Traditional 11/10/1988SE
K883525Oxalate ReagentLPW · Traditional 10/25/1988SE
K882965Krebs-Henseleit Bicarbonate Buffer No. K3753KIT · Traditional 08/04/1988SE
K880691Earle's Balanced Salts W/Out Phenol Red & SodiumKIT · Traditional 03/31/1988SE
K880596Eosin Y Solution, Alcoholic, with PhloxineHYB · Traditional 03/31/1988SE
K873095(Mem) Eagle No. M3149 W/Hanks' SaltsKIT · Traditional 08/25/1987SE
K873094(Mem) Eagle No. M7399 W/Earle's SaltsKIT · Traditional 08/25/1987SE
K873093(Mem) Eagle No. M3024 W/Earle's SaltsKIT · Traditional 08/25/1987SE
K873092RPMI-1640 Medium No. R7755 Auto-Mod(Tm) W.O/L-Glu.KIT · Traditional 08/25/1987SE
K873091Ames' Medium No. A1420 W/L-Gluta. W.O/Sod. Bicarb.KIT · Traditional 08/25/1987SE
K873090Medium 199 No. M3274 W/Hanks' Salts W.O/L-Glutami.KIT · Traditional 08/25/1987SE
K872912Triglyceride (UV) ReagentJGW · Traditional 08/17/1987SE
K872575HDL Cholesterol ReagentCHH · Traditional 07/16/1987SE
K872328Digoxin Fpia CalibratorsDLJ · Traditional 07/07/1987SE
K871589Theophylline Fpia ControlsLAW · Traditional 06/17/1987SE
K871476Silver Stain Reagent SystemLEF · Traditional 05/21/1987SE
K871477Neutral RedKFE · Traditional 04/29/1987SE
K871191(DMF/F-12) Hybri-Max(Tm) W/L-GlutamineKIT · Traditional 04/03/1987SE
K870530Medium 199 with Earle's Salts Product No. M2520KIT · Traditional 03/30/1987SE
K870529F-12 Medium, Coon's Modification Product No. F6636KIT · Traditional 03/30/1987SE
K870499Mccoy 5A Med (Mod) Suuspension Culture, M6523KIT · Traditional 03/30/1987SE
K870498Iscove Mod Dulbecco Med Hybri-Max, Product# I2510KIT · Traditional 03/30/1987SE
K870497BGJB Med(Fitton Jackson Mod)W/L-Glut/W/O Sod BicarKIT · Traditional 03/30/1987SE
K870496Dulbecco Modi Eagle Med((Dme) Hybri-Max (TM)KIT · Traditional 03/30/1987SE
K870495(Dme) Auto-Mod Modified for Autoclaving #D5280KIT · Traditional 03/30/1987SE
K870494RPMI-1640 Hybri-Max Product No. R8005KIT · Traditional 03/30/1987SE
K870493Nutrient Mixture F-12 (Ham) (Hepes Buffered) N4388KIT · Traditional 03/30/1987SE
K870492Dulbecco's Modified Eagle Medium Base No. D5030KIT · Traditional 03/30/1987SE
K870491Krebs-Ringer Bicarbonate Buffer Product No. K4002KIP · Traditional 03/30/1987SE
K870490(Dme) W/1000 MG Glucose/L No. D4655KIT · Traditional 03/30/1987SE
K870489Rpmi 1640 Medium W/L-Glutamine No. R8755KIT · Traditional 03/30/1987SE
K870488Rpmi 1640 Medium Defi. Modification No. R7130KIT · Traditional 03/30/1987SE
K870487H-Y Medium (DME:NCTC109, 7:1 Mix.) Hybri-Max H9014KIT · Traditional 03/30/1987SE
K870486Earle's Balanced Salts (Ebss) Hybri-Max #E9509KIP · Traditional 03/30/1987SE
K870485Lactalbumin Hydrolysate (Elah) No. L3762KIT · Traditional 03/30/1987SE
K870484Hanks' Balanced Salts (HBSS) No. H1387KIP · Traditional 03/30/1987SE
K870483Williams' Medium E W/L-Glutamine #W4125KIT · Traditional 03/30/1987SE
K870482(D-Pbs) Modified Hybri-Max Product No. D7030KIP · Traditional 03/30/1987SE
K870481(S-Mem) Auto-Mod Product No. M7272KIT · Traditional 03/30/1987SE
K870480NCTC 135 Medium Hybri-Max W/L-Glutamine #N5138KIT · Traditional 03/30/1987SE
K870479(Dme) Hybri-Max W/L-Glutamine Product No. D6780KIT · Traditional 03/30/1987SE
K870478Dulbecco's Mod. Eagle Med. Nut. Mix. F-12 #D2906KIT · Traditional 03/30/1987SE
K862319HBDH (Optimized) ReagentJMK · Traditional 07/07/1986SE
K861049High Molecular Weight Kininogen(Hmwk) Def PlasmaGGP · Traditional 05/29/1986SE
K861048Prekallikrein Deficient Plasma, Cat. No. B 6765GGP · Traditional 05/29/1986SE
K860029LDH (Optimized) ReagentCFJ · Traditional 02/06/1986SE
K850368Sigms B-Hydroxybutarate Procedure No. 310-UVJIN · Traditional 08/30/1985SE
K852568MCDB 201 Med Cat No. M6770 W/ Hepes & W0/ BicarbonKIT · Traditional 07/12/1985SE
K851609Sfre 199-2 Medium, Products No. S2138KIT · Traditional 05/15/1985SE
K851608SFRE199-1 Medium Product No. S 2013KIT · Traditional 05/15/1985SE
K851607MCDB 151 Medium, Product No. M6645KIT · Traditional 05/15/1985SE
K851606D-Pbs, Products No. D5652KIT · Traditional 05/15/1985SE
K851605Swin's S-77 Medium, Products S2513KIT · Traditional 05/15/1985SE
K851604CRCM-30 Medium Product No. C5030KIT · Traditional 05/15/1985SE
K850922Mem D-Val Modif. M7395, W/Ebss, L-Glutamine, D-ValKIT · Traditional 03/25/1985SE
K850921Mem, M7270, W/Ebss, L-Glutamine & W/O L-Leucine -KIT · Traditional 03/25/1985SE
K850891Dulbecco's Modified Eagle's Medium D7777, W/L-GlutKIT · Traditional 03/25/1985SE
K850890Mccoy's 5A M9270 W/L-Glutamine & W/O Phenol Red &KIT · Traditional 03/25/1985SE
K850364Glucose - Trinder- ReagentCGA · Traditional 03/05/1985SE
K850092Dulbecco's Modified Eagle's Med. (Dme) W/Glucose aKIT · Traditional 02/27/1985SE
K850091Basal Med. Eagle(Bme) W/Earle's Salts, L-GlutamineKIT · Traditional 02/27/1985SE
K850090Dulbecco's Modified Eagle's Med. (Dme) W/1000 Mg/LKIT · Traditional 02/27/1985SE
K850089Minimum Essential Med. (Mem) W/Earle's Sals L-GlutKIT · Traditional 02/27/1985SE
K845014Med. 199 W/Earle's Salts, L-Glutamine & 25MM HepesKIT · Traditional 02/27/1985SE
K845013RPMI-1640 Med. W/L-Glutamine & 25MM Hepes & W/O SoKIT · Traditional 02/27/1985SE
K845012Nutrient Mixture F-10 -Ham, N 1387, W/L-GlutamineKIT · Traditional 02/27/1985SE
K844808Methyl Green-Pyronin Stain Procedure HT70HZA · Traditional 02/25/1985SE
K844402Sigma Peroxidase Myeloperoxidase Staining ProcedurGIA · Traditional 01/04/1985SE
K843451Factor Xii Deficient Plasma B12DGGP · Traditional 11/19/1984SE
K843438Factor Xi Deficient Plasma B11DGGP · Traditional 11/19/1984SE
K843310Factor X Deficient Plasma, Blod HumanGGP · Traditional 11/19/1984SE
K843215Factor Ix Deficient Plasma, B9D -GGP · Traditional 11/19/1984SE
K843872Ethanol Controls Low & High E5133/E5258DKC · Traditional 10/31/1984SE
K843684Sigma Sudan Black Reagent 380-1HZZ · Traditional 10/31/1984SE
K843752Sigma Periodic Acid-Schiff Stain 395HZT · Traditional 10/30/1984SE
K843629Fetal Bovine Serum, F4884 Sterile GrowtKIS · Traditional 10/01/1984SE
K842366Oxalate Urine Controls Normal & ElevatJJW · Traditional 09/12/1984SE
K843086Dulbecco's Modified Eagle's Nutirent MixKIT · Traditional 08/28/1984SE
K843085RPMI-1640 Medium #R3505 W/Hat, L-GlutaKIT · Traditional 08/28/1984SE
K842776Minimum Essential Med W/L-GlutamineKIT · Traditional 08/20/1984SE
K842775Min. Essential Med. W/L-Glutamine, RibKIT · Traditional 08/17/1984SE
K843044Minim. Essential Med. Eagle M4144 W/KIT · Traditional 08/14/1984SE
K843043Med. 199 Catalog M3769 W/Earle's SaltKIT · Traditional 08/14/1984SE
K843045Lactalbumin Hydrolysate Med. CatalogKIT · Traditional 08/12/1984SE
K842564Sigma 59-UV for Alanine AminotransferCKA · Traditional 08/12/1984SE
K842411Sigma 58-UV Aspartate AminotransferasCIT · Traditional 08/12/1984SE
K842146HISTOPAQUE-1077JCF · Traditional 07/27/1984SE
K842672Minimum Essential Med. M0769 W/WoKIT · Traditional 07/20/1984SE
K842671Basal Med. Eagle B8265, W/Earls SaltsKIT · Traditional 07/20/1984SE
K842013Sigma Procedure 47-UVCGS · Traditional 06/25/1984SE
K842002Hanks Balanced Salts-Hbss H2387KIT · Traditional 06/22/1984SE
K841555Sigma Procedure 16-UVCFR · Traditional 05/22/1984SE
K841744Dulbecco's Phosphate Buffered SalineKIT · Traditional 05/11/1984SE
K841259Determination of Magnesium in Serum orJGJ · Traditional 05/07/1984SE
K834349Anti-Native DNA AntibodyKTL · Traditional 04/19/1984SE
K840243Determin. of Salicylate in Serum/PlastDKJ · Traditional 03/23/1984SE
K840926Formalin Solution 10% Neutral BufferIFP · Traditional 03/12/1984SE
K840798Amyloid Stain, Congo Red HT 60ICH · Traditional 03/12/1984SE
K840054Papanicolaou Stain Sys HT40HZJ · Traditional 02/17/1984SE
K833515Bouins SolutionIGN · Traditional 11/14/1983SE
K833424Veigert's Iron Hematoxylin STAIN-HT10-79HYO · Traditional 11/03/1983SE
K833394Medium 199 W/Hank's Salt W/L-GlutamineKIT · Traditional 11/03/1983SE
K833393Iscoe's Mod. Dulbecco's Med. W/GlutamKIT · Traditional 11/03/1983SE
K833392Waymouth MB 752/1 Med. W/L-GlutamineKIT · Traditional 11/03/1983SE
K833391Lactalbumin Hydrolysate Med. W/HanksKIT · Traditional 11/03/1983SE
K833390Tyrode's Salt Solution W/Sodium BicarKIT · Traditional 11/03/1983SE
K833389Medium 199 W/Earle's Salts W/L-GlutamKIT · Traditional 11/03/1983SE
K833388Iron Stain Procedure HT20LED · Traditional 10/31/1983SE
K833273Masson Trichrome Stain HT15ICN · Traditional 10/31/1983SE
K833167Trichrome Stain LG SolutionLED · Traditional 10/31/1983SE
K833169Mem W/L-Glutamine W/O Sodium BicarbonKIT · Traditional 10/28/1983SE
K833168Mem-Eagle-W/Earles Salts W/Neaa &KIT · Traditional 10/28/1983SE
K833166Procedure 460 for Determ. of ChlorideCHJ · Traditional 10/28/1983SE
K833165Fishers Med. for Leukemic Cells-MiceKIT · Traditional 10/28/1983SE
K833163Mem-Eagle W/Earles Salts W/IveaaKIT · Traditional 10/28/1983SE
K833164L-15-LEIBOVITZ W/L-GLUTAMINE-L4386KIT · Traditional 10/27/1983SE
K832953Mucicarmine Stain, #HT30HZC · Traditional 09/29/1983SE
K832930Spinner Salt Solution S-6011 W/EarlesKIT · Traditional 09/29/1983SE
K832929Ristocetin Platelet Aggrega-Reagent TestJBX · Traditional 09/29/1983SE
K832842Dulbeccos Modified Eagles Medium D5648KIT · Traditional 09/29/1983SE
K832841Nutrient Mixture F12 #N6760 W/L-GlutamKIT · Traditional 09/29/1983SE
K832836Basal Med. #B9763 W/Hanks Salts W/L-GKIT · Traditional 09/29/1983SE
K832835Dulbeccos Phosphate Buffered SalineKIT · Traditional 09/29/1983SE
K832840Minimum Essential Med. Eagle M4642 W/KIT · Traditional 09/26/1983SE
K832839Hanks Balanced Salt Mixture H6136KIT · Traditional 09/26/1983SE
K832838Earles Balanced Salt Mixture #E6132KIT · Traditional 09/26/1983SE
K832837Nutrient Mixture F-10 #N6635 W/L-GlutaKIT · Traditional 09/26/1983SE
K832690Minimum Essential Med. Eagle M0268KIT · Traditional 09/12/1983SE
K832689Mccoy's 5A #M4892 W/L-Glutamine andKIT · Traditional 09/12/1983SE
K832688Dulbecco's Modified Eagle #D5523-KIT · Traditional 09/12/1983SE
K832687Basal Med. Eagle #B9888 W/L-GlutamineKIT · Traditional 09/12/1983SE
K832236Sigma Procedure #550 Determ. BilirubCIG · Traditional 08/31/1983SE
K831745Basal Medium Eagle W/Earles Salts, &KIT · Traditional 07/06/1983SE
K831519RPMI-1640 Medium W/L-Glutamine &KIT · Traditional 06/22/1983SE
K822733Sigma Reagent System No. 885JBE · Traditional 12/03/1982SE
K822313Procedure #430 & Reagents for AcetaminLDP · Traditional 08/24/1982SE
K821574Eosin Y Solutin, AgueousHYB · Traditional 06/10/1982SE
K821573Eosin Y Solution AlcholicHYB · Traditional 06/09/1982SE
K821320Hematoxylin StainHYJ · Traditional 06/02/1982SE
K821062Hematoxylin SolutionHYJ · Traditional 04/29/1982SE
K812431Factor Viii Deficient Plasma #B8DGGP · Traditional 09/23/1981SE
K811864Sigma Procedure 265-UVCED · Traditional 07/31/1981SE
K811784Sigma Procedure #890GJS · Traditional 07/27/1981SE
K811011Histochemical Demonstration of LeukocyteGIA · Traditional 05/15/1981SE
K802721Glycohemoglobin in Whole BloodLCP · Traditional 12/11/1980SE
K801926Sigma Procedure #880 Fibrinogin/PlasmaKQJ · Traditional 09/09/1980SE
K800910Gal-Put Controls, Normal&DeficientJIX · Traditional 04/29/1980SE
K800301Sigma Procedure & Reagent System #335-UVCDT · Traditional 03/05/1980SE
K791794Factor Vii Deficient PlasmaGGP · Traditional 10/01/1979SE
K790760Reagent System #350HDL, Sigma ProcedureCHH · Traditional 05/23/1979SE
K790724Enzymatic DeterminationCHH · Traditional 05/23/1979SE
K790423Factor V DeficientGGP · Traditional 04/04/1979SE
K790211Dehydrogenose, Glucose PhosphateJBL · Traditional 03/15/1979SE
K790090Determination of Antithrombin III, 885JBQ · Traditional 02/26/1979SE
K781806Reagent System, Inorganic PhosphorusCEO · Traditional 01/17/1979SE
K781893Control, Protein ElectrophoresisJJY · Traditional 12/20/1978SE
K781859Reagent System, No 46-OV for CPKCGS · Traditional 12/04/1978SE
K780983Calcium Reagent System No. 585CIC · Traditional 07/27/1978SE
K780355AtroxinJCO · Traditional 04/18/1978SE
K771720Amido Black ConcentrateCEF · Traditional 11/03/1977SE
K771777Ponceau S ConcentrateHZO · Traditional 10/25/1977SE
K771916Procedure No. 555CGX · Traditional 10/19/1977SE
K771721Barbital Buffer · Traditional 10/18/1977SE
K771225Ap Isotrol, #A 0140CIN · Traditional 08/03/1977SE
K770902Colorimetric Determ. Socitrate Dehydro.JKH · Traditional 07/14/1977SE
K770577Deter. of Phosphohexose IsomeraseKLJ · Traditional 06/17/1977SE
K770495Quanti. Colori. Det. of Serum Iron · Traditional 06/08/1977SE
K770519Reagent System 153-UVJKG · Traditional 06/03/1977SE
K770049LDH Isotrol TJJT · Traditional 01/26/1977SE
K761212CPK1SOENZYMES Determination Pro. #715-EPJHY · Traditional 12/21/1976SE
K760711Reagent System (No. SC 135)JPZ · Traditional 11/30/1976SE
K760685Sigma Proced #SC165CJE · Traditional 11/24/1976SE
K760885Ketotrol-EJJX · Traditional 11/05/1976SE
K760863Product #K3002 Ketotrol-N(Urine Control)JJW · Traditional 11/02/1976SE
K760862Procedure No. 710-EP for Alk.Phos.CIN · Traditional 11/02/1976SE
K760591Sigma Procedure No. 745 - Ep.Reagent SyJHX · Traditional 10/29/1976SE
K760449Lipid ControlJJX · Traditional 10/29/1976SE
K760348Reagent System, Sigma Procedure No. 270CCZ · Traditional 10/27/1976SE
K760821Reagent SystemCJT · Traditional 10/21/1976SE
K760349Bilirubin Ref., Sigma Stock No. 605-10JIT · Traditional 10/05/1976SE
K760247Glucose Reagent Sys, Sigma Proced. 115CFR · Traditional 08/26/1976SE
K760332Sigma Ammonia ReagentJIF · Traditional 08/23/1976SE
K760131Agaro-Gel, Product # A1266JJN · Traditional 07/20/1976SE