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 Chemistry ✕

83 devices

1-12 of 83

Cleared Oct 20, 1987

STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 77d

Cleared Sep 29, 1987

STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 49d

Cleared Sep 14, 1987

STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 41d

Cleared Sep 02, 1987

PARAMAX URINE/CSF CALIBRATOR

Chemistry · 50d

Cleared Jul 31, 1987

AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

Chemistry · 53d

Cleared Jul 09, 1987

DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR

Chemistry · 48d

Cleared Jul 07, 1987

PARAMAX CHOLESTEROL REAGENT

Chemistry · 40d

Cleared Mar 19, 1987

STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.

Chemistry · 65d

Cleared Feb 25, 1987

Chemistry · 22d

Cleared Nov 05, 1986

SMI MULTIPETTOR(TM)

Chemistry · 30d

Cleared Sep 29, 1986

PARAMAX ELECTROLYTE CALIBRATOR

Chemistry · 20d

Cleared Aug 19, 1986

STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY

Chemistry · 54d

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