Medical Device Manufacturer · US , Deerfield , IL

Dade Intl., Inc. - FDA 510(k) Cleared Devices

30 submissions · 30 cleared · Since 1995

Recent clearances: DADE INNOVIN, DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/, DADE TRU-LIQUID CARDIAC CONTROL

30

Total

30

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dade Intl., Inc. Toxicology ✕

7 devices

1-7 of 7

Cleared Apr 25, 1997

PARAMAX SALICYLATE REAGENT

Toxicology · 151d

Cleared Sep 23, 1996

ACETAMINOPHEN FLEX REAGENT CARTRIDGE

Toxicology · 35d

Cleared Sep 16, 1996

DRUG CALIBRATOR II

Toxicology · 59d

Cleared Sep 13, 1996

TOBRAMYCIN FLEX REAGENT CARTRIDGE

Toxicology · 56d

Cleared Sep 13, 1996

GENTAMICIN FLEX REAGENT CARTRIDGE

Toxicology · 56d

Cleared Sep 13, 1996

CARBAMAZEPINE FLEX REAGENT CARTRIDGE

Toxicology · 56d

Cleared Sep 13, 1996

VANCOMYCIN FLEX REAGENT CARTRIDGE

Toxicology · 24d