Medical Device Manufacturer · US , Mchenry , IL

General Diagnostics - FDA 510(k) Cleared Devices

39 submissions · 39 cleared · Since 1976

39

Total

39

Cleared

0

Denied

FDA 510(k) Regulatory Record - General Diagnostics Toxicology ✕

8 devices

1-8 of 8

Cleared Sep 19, 1988

BARBITURATE ENZYME IMMUNOASSAY KIT

Toxicology · 84d

Cleared Nov 03, 1987

CANNABINOID ENZYME IMMUNOASSAY KIT

Toxicology · 104d

Cleared Jun 05, 1987

COCAINE METABOLITE ENZYME IMMUNOASSAY KIT

Toxicology · 65d

Cleared Mar 31, 1987

QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINE

Toxicology · 99d

Cleared Mar 12, 1987

BENZODIAZEPINE ENZYME IMMUNOASSAY KIT

Toxicology · 157d

Cleared Mar 25, 1982

PROFILE GENERAL SET ASSAYED SERUM CONTR

Toxicology · 31d

Cleared Dec 22, 1980

PROFILE CARDIAC SET ASSAYED SERUM CONTR.

Toxicology · 21d

Cleared Dec 22, 1980

PROFILE ANTI-CONVUL. SET ASSAYED S. CTL.

Toxicology · 21d