Company ยท US
Amersham Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 1992. Name variants (Inc, Corp, punctuation) are merged.
94510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| 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 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 4 |
| CGI | Radioimmunoassay, Estriol | 4 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 4 |
| JLS | Radioimmunoassay, Progesterone | 4 |
| KGI | Densitometer, Bone | 4 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 3 |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| IWJ | System, Applicator, Radionuclide, Manual | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1992 | K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 Amersham Corp. | CFT |
| Jul 22, 1991 | K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT Amersham Corp. | CIG |
| Jul 17, 1991 | K912766 | AMERLITE CK-MB ASSAY Amersham Corp. | JHY |
| Nov 2, 1990 | K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 Amersham Corp. | JLW |
| Jul 27, 1990 | K902760 | AMERSHAM TSH CONTROL SERA Amersham Corp. | JJX |
| Jul 9, 1990 | K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) Amersham Corp. | KGI |
| Jul 9, 1990 | K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) Amersham Corp. | KGI |
| Jul 9, 1990 | K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES Amersham Corp. | KGI |
| Jul 9, 1990 | K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 Amersham Corp. | KGI |
| Dec 12, 1989 | K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 Amersham Corp. | CHP |
| Oct 17, 1989 | K895872 | LAN.0800Q/2800Q Amersham Corp. | DBF |
| Sep 29, 1989 | K894409 | CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD Amersham Corp. | IWA |
| Sep 5, 1989 | K894329 | RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL Amersham Corp. | JJX |
| Aug 15, 1989 | K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT Amersham Corp. | CEE |
| Aug 3, 1989 | K894091 | AMERLEX-MAB FT4 KIT Amersham Corp. | CEC |
| Jun 2, 1989 | K893036 | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) Amersham Corp. | LRM |
| May 9, 1989 | K892362 | AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL) Amersham Corp. | DBF |
| Mar 20, 1989 | K890708 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE) Amersham Corp. | JJY |
| Mar 15, 1989 | K890414 | RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109) Amersham Corp. | JJY |
| Feb 8, 1989 | K885195 | AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT Amersham Corp. | CDP |
| Feb 6, 1989 | K890191 | HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN Amersham Corp. | IWJ |
| Dec 22, 1988 | K883123 | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT Amersham Corp. | CEC |
| Nov 16, 1988 | K884105 | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) Amersham Corp. | CHP |
| Nov 10, 1988 | K884100 | AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 Amersham Corp. | JLS |
| Nov 1, 1988 | K883878 | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) Amersham Corp. | CFT |
| Oct 11, 1988 | K882736 | AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA Amersham Corp. | JJY |
| Oct 6, 1988 | K882728 | AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190 Amersham Corp. | JJY |
| Oct 6, 1988 | K882475 | AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 Amersham Corp. | LFX |
| Sep 30, 1988 | K883124 | AMERLITE FREE THYROID CONTROL SERA LAN.4002 Amersham Corp. | JJY |
| Sep 22, 1988 | K882907 | AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT Amersham Corp. | JLW |
| Aug 8, 1988 | K882727 | AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 Amersham Corp. | JJY |
| Jul 28, 1988 | K880933 | AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST Amersham Corp. | CEP |
| Jul 21, 1988 | K881142 | AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST Amersham Corp. | CGJ |
| Jun 8, 1988 | K881355 | AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT Amersham Corp. | JHI |
| May 31, 1988 | K880823 | AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT Amersham Corp. | KXT |
| May 27, 1988 | K881373 | AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT Amersham Corp. | CDP |
| Apr 18, 1988 | K880934 | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT Amersham Corp. | JLS |
| Mar 24, 1988 | K880687 | CORTISOL ENHANCED LUMINESCENCE ASSAY KIT Amersham Corp. | CGR |
| Feb 18, 1988 | K874362 | AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144 Amersham Corp. | KHQ |
| Jan 27, 1988 | K874203 | AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800 Amersham Corp. | DBF |
| Nov 5, 1987 | K873976 | AMERLITE TT4 ASSAY (240/480/144 TEST KITS) Amersham Corp. | KLI |
| Nov 3, 1987 | K873858 | AMERLITE TT3 ASSAY, LAN.0003/1003/2003 Amersham Corp. | CDP |
| Feb 25, 1987 | K864855 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT Amersham Corp. | JLS |
| Mar 14, 1986 | K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) Amersham Corp. | CHO |
| Feb 11, 1986 | K860252 | AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA Amersham Corp. | CDP |
| Feb 11, 1986 | K860251 | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA Amersham Corp. | CEC |
| Jul 22, 1985 | K852675 | AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT Amersham Corp. | JHI |
| May 7, 1985 | K851361 | AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM Amersham Corp. | CGJ |
| Apr 10, 1985 | K851104 | AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT Amersham Corp. | CEP |
| Feb 1, 1985 | K845026 | AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE Amersham Corp. | JLS |
Newest 50 of 94.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||