Medical Device Manufacturer · US , Mchenry , IL

American Dade - FDA 510(k) Cleared Devices

149 submissions · 149 cleared · Since 1980

149

Total

149

Cleared

0

Denied

FDA 510(k) Regulatory Record - American Dade Toxicology ✕

10 devices

1-10 of 10

Cleared Jun 16, 1986

STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY

Toxicology · 17d

Cleared May 29, 1986

STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III

Toxicology · 80d

Cleared Feb 11, 1986

STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.

Toxicology · 28d

Cleared Feb 06, 1986

STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.

Toxicology · 23d

Cleared Sep 12, 1984

STRATUS QUINIDINE FLUOROMETRIC ENZYME

Toxicology · 21d

Cleared Jul 11, 1984

STRATUS PRIMIDONE FLOROMETRIC ENZY

Toxicology · 37d

Cleared May 16, 1984

COMA TOXICOLOGY CONTROL

Toxicology · 40d

Cleared Apr 19, 1984

PARAMAX CHLORIDE REAGENT

Toxicology · 38d

Cleared May 13, 1983

STRATUS PHENOBARBITAL FLUOROMETRIC ENZ

Toxicology · 67d

Cleared Dec 22, 1980

IMMU-TRACE DIGOXIN (125I) RADIOIMMUN.

Toxicology · 21d