Fisher Scientific Co., LLC
Medical device manufacturer in Pittsburgh, PA.
89510(k) clearances
1PMA approvals
2recalls
Device types
- CHL Electrode Measurement, Blood-Gases (Pco2… 15
- JPK Mixture, Hematology Quality Control 5
- JJY Multi-Analyte Controls, All Kinds (Assayed) 5
- DIF Drug Mixture Control Materials 4
- JGS Electrode, Ion Specific, Sodium 3
- CIG Diazo Colorimetry, Bilirubin 2
- CIX Bromcresol Green Dye-Binding, Albumin 2
- CEK Biuret (Colorimetric), Total Protein 2
- JJS Controls For Blood-Gases, (Assayed And… 2
- JFS Coulometric, Chloride 2
- JSC Culture Media, General Nutrient Broth 2
- JIT Calibrator, Secondary 2
- GKF Instrument, Hematocrit, Automated 2
- CGX Alkaline Picrate, Colorimetry, Creatinine 2
- JPI Device, Hematocrit Measuring 2
- JHS Differential Rate Kinetic Method, Cpk Or… 2
- JIX Calibrator, Multi-Analyte Mixture 2
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- CEM Electrode, Ion Specific, Potassium 1
- GKG Centrifuge, Hematocrit 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K930415 | Microhematocrit RotorGKG · Traditional | 03/23/1993SE |
| K915825 | Marathon 6K General-Purpose CentrifugeGKF · Traditional | 03/11/1992SE |
| K915441 | Marathon 13K/H Microhematocrit CentrifugeGKF · Traditional | 01/08/1992SE |
| K890534 | Modified Uriqual(Tm) Urinalysis Control Level 1JJW · Traditional | 03/08/1989SE |
| K881275 | Uriqual(Tm) Urinalysis Controls (Human) I & IIJJY · Traditional | 05/16/1988SE |
| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | 09/14/1987SE |
| K871058 | Serachem Liquid Spinal Fluid Control (Human)JJY · Traditional | 04/06/1987SE |
| K863224 | Hematall-C Plus Hematology ControlsJPK · Traditional | 10/29/1986SE |
| K862318 | Fisher Diagnostics Hematall-C CalibratorJPK · Traditional | 07/10/1986SE |
| K861185 | Therachem-Plus, Tri-Level TDC (TM)JJY · Traditional | 05/23/1986SE |
| K860919 | Therachem, TDC Therapeutic Drug ControlsDIF · Traditional | 04/11/1986SE |
| K853241 | Hematology Stain PackIAF · Traditional | 08/19/1985SE |
| K851151 | Fisher Diagnostics Kda Calibrator IIJIX · Traditional | 05/20/1985SE |
| K851150 | Fisher Diagnostics Kda Calibrator IJIX · Traditional | 05/20/1985SE |
| K850636 | Simutaneous Fixation & Decalcifying Solution Cal-EKDX · Traditional | 03/20/1985SE |
| K844168 | Amylase Reagent CS-726CJA · Traditional | 11/20/1984SE |
| K843452 | Standard & Solutions for Nova 4 AnalyzJGS · Traditional | 09/27/1984SE |
| K840111 | Total BilirubinCIG · Traditional | 03/19/1984SE |
| K833950 | Total Protein Reagent CS-724CEK · Traditional | 01/13/1984SE |
| K833712 | Na/K Fluida Pack for Nova 1 AnalyzerJGS · Traditional | 01/13/1984SE |
| K833699 | Albumin Reagent CS-716CIX · Traditional | 01/13/1984SE |
| K833035 | Calcium Dye REAGENT-CS-718-A/BUFFERCIC · Traditional | 11/03/1983SE |
| K832879 | B-Slide Pregnate Pregnancy Test KitJHJ · Traditional | 10/28/1983SE |
| K831025 | Electrolyle Carbon Dioxide ElectrodesCHL · Traditional | 06/16/1983SE |
| K831024 | Electrolyte PO2 for Oxygen ElectrodesCHL · Traditional | 06/16/1983SE |
| K831021 | Calibrating Solution for ABL-1 & 2CHL · Traditional | 06/16/1983SE |
| K831019 | PH 6.838 Ref. BufferCHL · Traditional | 06/16/1983SE |
| K831018 | Calibrating Solution for ABL-1 & 2CHL · Traditional | 06/16/1983SE |
| K831023 | Reference Buffer PH 7.382CHL · Traditional | 06/15/1983SE |
| K831013 | Diagnostics Po 2 ElectrolyteCHL · Traditional | 06/08/1983SE |
| K831012 | Diagnostics PCO2 Electrolyte W/CarbonCHL · Traditional | 06/08/1983SE |
| K831015 | Diagnostics PH Electrode Cleaning SolutCHL · Traditional | 05/25/1983SE |
| K831020 | Flush Solution ConcentrateCHL · Traditional | 05/09/1983SE |
| K831017 | Buffer Pack for ABL-1 & ABL-2CHL · Traditional | 05/09/1983SE |
| K831016 | Bath ClearCHL · Traditional | 05/05/1983SE |
| K831010 | Diagnostics PO2 Electrode CleanerCHL · Traditional | 05/05/1983SE |
| K830578 | Microhematocrit ReaderJPI · Traditional | 03/24/1983SE |
| K830217 | Reagents Corning Chloride Meter forJFS · Traditional | 02/18/1983SE |
| K823930 | Hematology Quality Control MixtureGJP · Traditional | 02/01/1983SE |
| K823929 | Multianalyte Controls-All KindsJJY · Traditional | 01/28/1983SE |
| K823558 | Micro-Hematocrit Centrifuge 335/336JPI · Traditional | 01/21/1983SE |
| K822905 | Latest RF Kit for Rheumatoid FactorDHR · Traditional | 10/18/1982SE |
| K822496 | Sera Chem Smac CalibratorsJIT · Traditional | 09/21/1982SE |
| K822352 | Hematoxylin Stain SolutionHYJ · Traditional | 08/16/1982SE |
| K821683 | Reagent for Coulter Counter Model 5+11GIF · Traditional | 06/24/1982SE |
| K820731 | Hematall-C Plus Hematology ControlsJPK · Traditional | 05/12/1982SE |
| K820996 | Salmonella & Shigella Grouping SeraGRL · Traditional | 05/03/1982SE |
| K813505 | Flame Photometer Calibration StandardsJIS · Traditional | 12/31/1981SE |
| K812623 | Cleaning Solution for Radiometer OSM2CHL · Traditional | 11/02/1981SE |
| K812553 | Aqueous Blood Gas ControlsJJS · Traditional | 09/23/1981SE |
| K812335 | Trypticase Soy Broth Blood Culture BottJSC · Traditional | 09/09/1981SE |
| K811182 | Multianalyte Controls, All KindsJJY · Traditional | 05/15/1981SE |
| K810504 | Therachem Anti Convulsanta TheophyllineDIF · Traditional | 03/11/1981SE |
| K802672 | Cardioactive Drugs ControlDIF · Traditional | 11/24/1980SE |
| K800220 | Calibrator No. 1 & 2, & Wash SolutionJIT · Traditional | 02/26/1980SE |
| K800219 | Serum Creatinine; Alk. Buffer & PicricCGX · Traditional | 02/26/1980SE |
| K800218 | Carbon Dioxide Cup Reagent & Ref.Rgt.JFL · Traditional | 02/26/1980SE |
| K800217 | Chloride Reagent, Cup & CleanerJFS · Traditional | 02/26/1980SE |
| K800216 | Sodium/Potassium Conditioning ReagentJGS · Traditional | 02/26/1980SE |
| K800071 | Bun Reagent KitCDS · Traditional | 02/05/1980SE |
| K800070 | Glucose Oxidase Reagent KitCGA · Traditional | 02/05/1980SE |
| K792056 | Fisher Diagnostics Anaerobic Blood CultJSC · Traditional | 11/16/1979SE |
| K792143 | Fisher Diag. Prime Blood Gas ControlsJJS · Traditional | 11/13/1979SE |
| K792138 | Smac (Sequential Mult. Analysis Comp.CEK · Traditional | 11/13/1979SE |
| K792055 | Fisher Diagnostics Hematology ControlsJPK · Traditional | 11/05/1979SE |
| K791760 | Glucose Hexokinase Coil Reagent SystemCFR · Traditional | 09/27/1979SE |
| K790525 | Hematrol S Hematology ControlsJPK · Traditional | 04/03/1979SE |
| K790498 | Liss ReagentKSG · Traditional | 04/03/1979SE |
| K790319 | Ortho-Toluidine Reagent SetCGE · Traditional | 03/21/1979SE |
| K782128 | Thera ChemDIF · Traditional | 03/02/1979SE |
| K790019 | Serum, Uric Acid DeterminationCDH · Traditional | 02/26/1979SE |
| K790017 | Serum, Glutamic-OxaloaceticCIT · Traditional | 02/26/1979SE |
| K790021 | Serum, Inorganic PhosphorousCEO · Traditional | 02/15/1979SE |
| K790016 | Serum, Glutamic-PyruvicCKA · Traditional | 02/15/1979SE |
| K790015 | Serum, Creatinine PhosphokinaseJHS · Traditional | 02/15/1979SE |
| K790020 | Serum, Lactic DehydrogenaseCFJ · Traditional | 02/08/1979SE |
| K790018 | Serum, Potassium Determination ofCEM · Traditional | 02/01/1979SE |
| K782160 | Total Iron in SerumJIY · Traditional | 01/26/1979SE |
| K781885 | Serum, Blood Urea NitiogenCDW · Traditional | 12/20/1978SE |
| K781884 | Serum, Creatinine DeterminationsCGX · Traditional | 12/20/1978SE |
| K781740 | Reagent, HDLCHH · Traditional | 11/22/1978SE |
| K781690 | L-Cysteine HydrochlorideJHS · Traditional | 10/27/1978SE |
| K781611 | Cholesterol Det. in SerumCGO · Traditional | 10/24/1978SE |
| K781610 | Bilirubin Determintaiton in SerumCIG · Traditional | 10/24/1978SE |
| K781609 | Alkaline Phosphatase in SerumCJE · Traditional | 10/24/1978SE |
| K781466 | Automated Enzymatic Triglyceride ReagentCDT · Traditional | 10/03/1978SE |
| K772307 | Pco 2 ElectrolyteCHL · Traditional | 12/22/1977SE |
| K760543 | Bromcresol GreenCIX · Traditional | 11/01/1976SE |
PMA approvals
- P770001 Fluorescent Gonorrhea Test-Heated (Fgt-H) · 07/18/1979 · 0 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1521-2014 Class II | Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025…A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator… | 02/05/2014Terminated |
| Z-1955-2013 Class II | Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100…The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of… | 06/05/2013Terminated |