Amersham Corp.
Medical device manufacturer in Arlington Heights, IL.
94510(k) clearances
0PMA approvals
0recalls
Device types
- CDP Radioimmunoassay, Total Triiodothyronine 7
- JJY Multi-Analyte Controls, All Kinds (Assayed) 7
- DBF Ferritin, Antigen, Antiserum, Control 6
- CEC Radioimmunoassay, Free Thyroxine 5
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 5
- CGJ Radioimmunoassay, Follicle-Stimulating… 4
- CEP Radioimmunoassay, Luteinizing Hormone 4
- KGI Densitometer, Bone 4
- CGI Radioimmunoassay, Estriol 4
- JLS Radioimmunoassay, Progesterone 4
- KHQ Radioassay, Triiodothyronine Uptake 3
- JJX Single (Specified) Analyte Controls… 3
- CFT Radioimmunoassay, Prolactin (Lactogen) 3
- JHI Visual, Pregnancy Hcg, Prescription Use 3
- CHP Radioimmunoassay, Estradiol 2
- IWJ System, Applicator, Radionuclide, Manual 2
- CGR Radioimmunoassay, Cortisol 2
- CGN Acid, Folic, Radioimmunoassay 2
- KTL Anti-Dna Indirect Immunofluorescent Solid… 1
- JIT Calibrator, Secondary 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
| K895872 | LAN.0800Q/2800QDBF · Traditional | 10/17/1989SE |
| K894409 | CESIUM-137 Microseed Source Train Assembly/ShieldIWA · Traditional | 09/29/1989SE |
| K894329 | Radioassay Controls 31 & 32, Anti-Dsdna ControlJJX · Traditional | 09/05/1989SE |
| K893469 | Amerlite TBG Assay, LAN.0005/1005 240/144 Test KitCEE · Traditional | 08/15/1989SE |
| K894091 | Amerlex-Mab FT4 KitCEC · Traditional | 08/03/1989SE |
| K893036 | Anti-Dsdna Kit, IM.77/771 (50/100 Test Kits)LRM · Traditional | 06/02/1989SE |
| K892362 | Amerlite Ferritin Assay (Additional Protocol)DBF · Traditional | 05/09/1989SE |
| K890708 | Amerlite Reproductive Endocrinology (Label Change)JJY · Traditional | 03/20/1989SE |
| K890414 | Radioassay Controls 19,20,21,33,34 & 35 (QAS.109)JJY · Traditional | 03/15/1989SE |
| K885195 | Amerlite FT3 Assay, LAN.0007/2007 240/144 Test KitCDP · Traditional | 02/08/1989SE |
| K890191 | Handling & Cutting Device for IRIDIUM-192 Wire PinIWJ · Traditional | 02/06/1989SE |
| K883123 | Amerliite FT4 Assay LAN.0006/2006 240/144 Test KitCEC · Traditional | 12/22/1988SE |
| K884105 | Amerlite Estradiol Assay, LAN.2080 (144 Test Kit)CHP · Traditional | 11/16/1988SE |
| K884100 | Amerlite Progesterone Assay, LAN.0079/2079 240/144JLS · Traditional | 11/10/1988SE |
| K883878 | Amerlite Prolactin Assay, LAN.0078/2078(240/144)CFT · Traditional | 11/01/1988SE |
| K882736 | Amerlite Reproductive Endocrinology Control SeraJJY · Traditional | 10/11/1988SE |
| K882728 | Amerlite Endocrinology Control Sera LAN.4190JJY · Traditional | 10/06/1988SE |
| K882475 | Amerlite Rubella Antibody Assay, LAN.0200/2200LFX · Traditional | 10/06/1988SE |
| K883124 | Amerlite Free Thyroid Control Sera LAN.4002JJY · Traditional | 09/30/1988SE |
| K882907 | Amerlite TSH Assay, LAN.0001/2001 240 & 144 KitJLW · Traditional | 09/22/1988SE |
| K882727 | Amerlite Total Thyroid Control Sera LAN.4001JJY · Traditional | 08/08/1988SE |
| K880933 | Amerlite LH-30 Assay, LAN.0082/2082 240/144 TestCEP · Traditional | 07/28/1988SE |
| K881142 | Amerlite FSH Assay, LAN.0077/2077 240 and 144 TestCGJ · Traditional | 07/21/1988SE |
| K881355 | Amerlite HCG-60 Assay, LAN.0083/2083 240KIT/144KITJHI · Traditional | 06/08/1988SE |
| K880823 | Amerlite Digoxin Assay, LAN.0700/2700, 240/144 KitKXT · Traditional | 05/31/1988SE |
| K881373 | Amerlite TT3 Assay, LAN.0003/2003 240/144 KitCDP · Traditional | 05/27/1988SE |
| K880934 | Modified Amerlex-M Progesterone Radioimmuno. KitJLS · Traditional | 04/18/1988SE |
| K880687 | Cortisol Enhanced Luminescence Assay KitCGR · Traditional | 03/24/1988SE |
| K874362 | Amerlite T3U Assay LAN.0004/1004/2004, 240/480/144KHQ · Traditional | 02/18/1988SE |
| K874203 | Amerlite Ferritin Assay, LAN.0800/1800/2800DBF · Traditional | 01/27/1988SE |
| K873976 | Amerlite TT4 Assay (240/480/144 Test Kits)KLI · Traditional | 11/05/1987SE |
| K873858 | Amerlite TT3 Assay, LAN.0003/1003/2003CDP · Traditional | 11/03/1987SE |
| K864855 | Amerlex-M Progesterone Radioimmunoassay KitJLS · Traditional | 02/25/1987SE |
| K860253 | Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit)CHO · Traditional | 03/14/1986SE |
| K860252 | Amerlex-M T3 Ria Kit for Serum and PlasmaCDP · Traditional | 02/11/1986SE |
| K860251 | Amerlex-M T4 Ria Kit for Serum and PlasmaCEC · Traditional | 02/11/1986SE |
| K852675 | Amerlex-M B-Human Chorionic Gonadtropin Radioi KitJHI · Traditional | 07/22/1985SE |
| K851361 | Amerlex-M Follicle Stimulating Hormone(Fsh)RadioimCGJ · Traditional | 05/07/1985SE |
| K851104 | Amerlex-M Luteinizing Hormone Radioimmuno-KitCEP · Traditional | 04/10/1985SE |
| K845026 | Amerlex-M Progesterone Radioimmunoassay Kit CodeJLS · Traditional | 02/01/1985SE |
| K844408 | Amerlex-M Specific Estriol UnconjugatedCGI · Traditional | 12/11/1984SE |
| K842949 | Amerlex-M Free T-3 RiaCDP · Traditional | 09/05/1984SE |
| K842948 | Amerlex-M TSH RiaJLW · Traditional | 09/04/1984SE |
| K842482 | Amerlex-M Free T-4 Radioimmunoassay KitCEC · Traditional | 08/10/1984SE |
| K840588 | Amerlex Human Placental LactogenJMF · Traditional | 04/04/1984SE |
| K830980 | Amerlex Free T-3 Ria KitCDP · Traditional | 05/25/1983SE |
| K821031 | Amerlex B-Lcg Ria KitJHI · Traditional | 05/03/1982SE |
| K820754 | Amerlex Esh KitCGJ · Traditional | 04/15/1982SE |
| K820753 | Amerlex LH Ria Kit (Code IM2081)CEP · Traditional | 04/09/1982SE |
| K812979 | Vitamin B12/FOLATE Dual Radioassay KitsCGN · Traditional | 11/24/1981SE |
| K812236 | Gold(Au 195) Gamma Camera Check(Flood)IYO · Traditional | 09/09/1981SE |
| K812235 | Gold(Au 195) Spot Marker SourcesIXD · Traditional | 09/09/1981SE |
| K812136 | Amerlex TSH Ria KitJLW · Traditional | 08/13/1981SE |
| K811804 | Ferritin Ria KitDBF · Traditional | 07/10/1981SE |
| K811169 | Prostatic Acid Phosphatase (Pap) Rda KitJFH · Traditional | 05/15/1981SE |
| K810667 | Amerlex Estriol Ria KitCGI · Traditional | 03/31/1981SE |
| K810231 | Code Im 2050 Amerlex Free T4 Ria KitCEC · Traditional | 02/10/1981SE |
| K803097 | Digoxin & Phenytoin Control SeraDIF · Traditional | 12/22/1980SE |
| K801561 | Glycosylated Hemoglobin KitLCP · Traditional | 08/12/1980SE |
| K801413 | Amerlex Digoxin Ria KitLCS · Traditional | 07/08/1980SE |
| K800867 | Dose Calibration Ref. Sources; BARIUM-13 · Traditional | 05/28/1980SE |
| K800740 | Prolactin Ria KitCFT · Traditional | 04/16/1980SE |
| K800708 | Code QAS.105 Prolactin Control SeraJJX · Traditional | 04/16/1980SE |
| K800700 | Amerlex Cortisol Ria KitCGR · Traditional | 04/16/1980SE |
| K800657 | Ferritin Controls Code QAS.104DBF · Traditional | 04/16/1980SE |
| K800320 | CESIUM-137 Afterloading System /Gyn.Bra.IWJ · Traditional | 03/25/1980SE |
| K800374 | Amerlex T-3 Ria KitCDP · Traditional | 03/12/1980SE |
| K800300 | Amerlex T-4 Ria KitCDX · Traditional | 03/05/1980SE |
| K800299 | Ferritin Ria KitDBF · Traditional | 03/03/1980SE |
| K800036 | Total Estriol Ria KitCGI · Traditional | 01/21/1980SE |
| K792290 | TSH Standards & DiluentJIT · Traditional | 12/06/1979SE |
| K791354 | Code Qas 103 Anti-Dna ControlsKTL · Traditional | 09/17/1979SE |
| K790840 | Thyroid Control Sera Code QAS.101JJY · Traditional | 06/28/1979SE |
| K790461 | T-3 Uptake (Maa) KitKHQ · Traditional | 05/03/1979SE |
| K781685 | Ria Kit, LHCEP · Traditional | 10/27/1978SE |
| K780799 | Vitamin B12 RadioassayCDD · Traditional | 06/13/1978SE |
| K780726 | TSH Ria KitJLW · Traditional | 06/13/1978SE |
| K780525 | T-3 Uptake (Sorbent) KitKHQ · Traditional | 05/19/1978SE |
| K772215 | Unconjugated Estriol Ria KitCGI · Traditional | 12/22/1977SE |
| K770779 | Phenytoin Ria KitDLP · Traditional | 06/17/1977SE |
| K770397 | Monitor, Radioisotope, Model 9273A · Traditional | 03/10/1977SE |
| K761309 | Ob-Gyn Control Sera (Code 196300)JIX · Traditional | 12/30/1976SE |
| K760373 | Radioassay Kit, IM.72 FSHCGJ · Traditional | 11/01/1976SE |
| K760207 | Kit, Folate Radioassay SC.7CGN · Traditional | 07/26/1976SE |