Medical Device Manufacturer · US , Mchenry , IL

Amersham Corp. - FDA 510(k) Cleared Devices

94 submissions · 94 cleared · Since 1976

94

Total

94

Cleared

0

Denied

FDA 510(k) Regulatory Record - Amersham Corp. Chemistry ✕

66 devices

1-12 of 66

Cleared Feb 18, 1992

AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

Chemistry · 155d

Cleared Jul 22, 1991

AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT

Chemistry · 32d

Cleared Jul 17, 1991

AMERLITE CK-MB ASSAY

Chemistry · 23d

Cleared Nov 02, 1990

AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008

Chemistry · 18d

Cleared Jul 27, 1990

AMERSHAM TSH CONTROL SERA

Chemistry · 32d

Cleared Dec 12, 1989

AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081

Chemistry · 42d

Cleared Sep 05, 1989

RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL

Chemistry · 53d

Cleared Aug 03, 1989

AMERLEX-MAB FT4 KIT

Chemistry · 55d

Cleared Mar 20, 1989

AMERLITE REPRODUCTIVE ENDOCRINOLOGY (LABEL CHANGE)

Chemistry · 48d

Cleared Mar 15, 1989

RADIOASSAY CONTROLS 19,20,21,33,34 & 35 (QAS.109)

Chemistry · 50d

Cleared Feb 08, 1989

AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT

Chemistry · 54d

Cleared Dec 22, 1988

AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT

Chemistry · 149d

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