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. Immunology ✕

10 devices

1-10 of 10

Cleared Oct 17, 1989

LAN.0800Q/2800Q

Immunology · 13d

Cleared Jun 02, 1989

ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)

Immunology · 39d

Cleared May 09, 1989

AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

Immunology · 33d

Cleared Jan 27, 1988

AMERLITE FERRITIN ASSAY, LAN.0800/1800/2800

Immunology · 104d

Cleared Apr 16, 1980

FERRITIN CONTROLS CODE QAS.104

Immunology · 22d

Cleared Mar 03, 1980

FERRITIN RIA KIT

Immunology · 21d

Cleared Sep 17, 1979

CODE QAS 103 ANTI-DNA CONTROLS

Immunology · 61d

Cleared Dec 22, 1977

UNCONJUGATED ESTRIOL RIA KIT

Immunology · 20d

Cleared Dec 30, 1976

OB-GYN CONTROL SERA (CODE 196300)

Immunology · 7d

Cleared Nov 01, 1976

RADIOASSAY KIT, IM.72 FSH

Immunology · 88d