Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Amersham Corp. — Predicate Candidate Screening

94 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

40 daysmedian FDA review time

97 days90th percentile

94clearances measured

K-number	Device	Applicant	Decided	Review days
K914135	AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086	Amersham Corp.	1992-02-18	155
K912733	AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT	Amersham Corp.	1991-07-22	32
K912766	AMERLITE CK-MB ASSAY	Amersham Corp.	1991-07-17	23
K904666	AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008	Amersham Corp.	1990-11-02	18
K902760	AMERSHAM TSH CONTROL SERA	Amersham Corp.	1990-07-27	32
K901854	GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)	Amersham Corp.	1990-07-09	76
K901832	GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415	Amersham Corp.	1990-07-09	76
K901857	GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)	Amersham Corp.	1990-07-09	76
K901848	GADOLINIUM-153 BONE DENSITOMETER SOURCES	Amersham Corp.	1990-07-09	76
K896270	AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081	Amersham Corp.	1989-12-12	42
K895872	LAN.0800Q/2800Q	Amersham Corp.	1989-10-17	13
K894409	CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELD	Amersham Corp.	1989-09-29	74
K894329	RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL	Amersham Corp.	1989-09-05	53
K893469	AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT	Amersham Corp.	1989-08-15	103
K894091	AMERLEX-MAB FT4 KIT	Amersham Corp.	1989-08-03	55
K893036	ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)	Amersham Corp.	1989-06-02	39
K892362	AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)	Amersham Corp.	1989-05-09	33
K890708	AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)	Amersham Corp.	1989-03-20	48
K890414	RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)	Amersham Corp.	1989-03-15	50
K885195	AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT	Amersham Corp.	1989-02-08	54
K890191	HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN	Amersham Corp.	1989-02-06	19
K883123	AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT	Amersham Corp.	1988-12-22	149
K884105	AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)	Amersham Corp.	1988-11-16	48
K884100	AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144	Amersham Corp.	1988-11-10	43
K883878	AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)	Amersham Corp.	1988-11-01	49
K882736	AMERLITE REPRODUCTIVE ENDOCRINOLOGY CONTROL SERA	Amersham Corp.	1988-10-11	102
K882728	AMERLITE ENDOCRINOLOGY CONTROL SERA LAN.4190	Amersham Corp.	1988-10-06	97
K882475	AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200	Amersham Corp.	1988-10-06	113
K883124	AMERLITE FREE THYROID CONTROL SERA LAN.4002	Amersham Corp.	1988-09-30	66
K882907	AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT	Amersham Corp.	1988-09-22	72
K882727	AMERLITE TOTAL THYROID CONTROL SERA LAN.4001	Amersham Corp.	1988-08-08	38
K880933	AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST	Amersham Corp.	1988-07-28	143
K881142	AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST	Amersham Corp.	1988-07-21	126
K881355	AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT	Amersham Corp.	1988-06-08	51
K880823	AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT	Amersham Corp.	1988-05-31	91
K881373	AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT	Amersham Corp.	1988-05-27	56
K880934	MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT	Amersham Corp.	1988-04-18	42
K880687	CORTISOL ENHANCED LUMINESCENCE ASSAY KIT	Amersham Corp.	1988-03-24	31
K874362	AMERLITE T3U ASSAY LAN.0004/1004/2004, 240/480/144	Amersham Corp.	1988-02-18	118
K874203	AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800	Amersham Corp.	1988-01-27	104
K873976	AMERLITE TT4 ASSAY (240/480/144 TEST KITS)	Amersham Corp.	1987-11-05	37
K873858	AMERLITE TT3 ASSAY, LAN.0003/1003/2003	Amersham Corp.	1987-11-03	42
K864855	AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT	Amersham Corp.	1987-02-25	76
K860253	AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)	Amersham Corp.	1986-03-14	49
K860252	AMERLEX-M T3 RIA KIT FOR SERUM AND PLASMA	Amersham Corp.	1986-02-11	18
K860251	AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA	Amersham Corp.	1986-02-11	18
K852675	AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT	Amersham Corp.	1985-07-22	28
K851361	AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM	Amersham Corp.	1985-05-07	33
K851104	AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT	Amersham Corp.	1985-04-10	22
K845026	AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE	Amersham Corp.	1985-02-01	36

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda