Medical Device Manufacturer · US , Mchenry , IL

Dade, Baxter Travenol Diagnostics, Inc. - FDA 510(k) Cleared Devices

44 submissions · 44 cleared · Since 1976

44

Total

44

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dade, Baxter Travenol Diagnostics, Inc. Hematology ✕

18 devices

1-12 of 18

Cleared Feb 13, 1980

WHOLE BLOOD PLATELET CONTROL NORMAL,

Hematology · 57d

Cleared May 23, 1979

IMMU-TEK AUTOMATIC CENTRIFUGE

Hematology · 34d

Cleared May 23, 1979

DADE LOW IONIC STRENGTH SOLUITION (LISS)

Hematology · 33d

Cleared Apr 23, 1979

Hematology · 31d

Cleared Mar 12, 1979

PLASMA, STANDARDIZED NORMAL

Hematology · 41d

Cleared Feb 15, 1979

Hematology · 171d

Cleared Jan 17, 1979

REAGENT, LYSING AND HEMOGLOBIN

Hematology · 30d

Cleared Nov 08, 1978

ANTITHROMBIN III ASSAY

Hematology · 72d

Cleared Jul 27, 1978

CONTROL, HEMATOLOGY, CH-60

Hematology · 29d

Cleared Mar 02, 1978

PLATELET AGGREGATING REAGENTS

Hematology · 52d

Cleared Mar 02, 1978

IMMUFUGE DISP. LINER

Hematology · 9d

Cleared Aug 25, 1977

PLATELET CONTROLS NORMAL & ABNORMAL

Hematology · 7d