Amersham Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
94
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086February 18, 1992
K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITJuly 22, 1991
K912766AMERLITE CK-MB ASSAYJuly 17, 1991
K904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008November 2, 1990
K902760AMERSHAM TSH CONTROL SERAJuly 27, 1990
K901848GADOLINIUM-153 BONE DENSITOMETER SOURCESJuly 9, 1990
K901857GADOLINIUM-153 BONE DENSITOMETER (GDC.10413)July 9, 1990
K901854GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412)July 9, 1990
K901832GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415July 9, 1990
K896270AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081December 12, 1989
K895872LAN.0800Q/2800QOctober 17, 1989
K894409CESIUM-137 MICROSEED SOURCE TRAIN ASSEMBLY/SHIELDSeptember 29, 1989
K894329RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROLSeptember 5, 1989
K893469AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KITAugust 15, 1989
K894091AMERLEX-MAB FT4 KITAugust 3, 1989
K893036ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)June 2, 1989
K892362AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)May 9, 1989
K890708AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)March 20, 1989
K890414RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)March 15, 1989
K885195AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KITFebruary 8, 1989