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
1-18 of 18
Cleared Feb 13, 1980
WHOLE BLOOD PLATELET CONTROL NORMAL,
K792606 · JPK
Hematology · 57d
Cleared May 23, 1979
IMMU-TEK AUTOMATIC CENTRIFUGE
K790767 · KSN
Hematology · 34d
Cleared May 23, 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
K790776 · KSG
Hematology · 33d
Cleared Apr 23, 1979
QUIK-STAIN
K790571 · IAF
Hematology · 31d
Cleared Mar 12, 1979
PLASMA, STANDARDIZED NORMAL
K790204 · JPA
Hematology · 41d
Cleared Feb 15, 1979
HEPARIN ASSAY
K781479 · KFF
Hematology · 171d
Cleared Jan 17, 1979
REAGENT, LYSING AND HEMOGLOBIN
K782098 · GGK
Hematology · 30d
Cleared Nov 08, 1978
ANTITHROMBIN III ASSAY
K781480 · JBQ
Hematology · 72d
Cleared Jul 27, 1978
CONTROL, HEMATOLOGY, CH-60
K781077 · JPK
Hematology · 29d
Cleared Mar 02, 1978
PLATELET AGGREGATING REAGENTS
K780047 · JOZ
Hematology · 52d
Cleared Mar 02, 1978
IMMUFUGE DISP. LINER
K780281 · KSO
Hematology · 9d
Cleared Aug 25, 1977
PLATELET CONTROLS NORMAL & ABNORMAL
K771588 · GJP
Hematology · 7d
Cleared Aug 22, 1977
CI-TROL COAGULATION CONTROLS II & III
K771346 · GGN
Hematology · 33d
Cleared Aug 02, 1977
WHOLE BLOOD GAS CONTROL
K770950 · JJS
Hematology · 69d
Cleared Nov 24, 1976
AUTO-FI COAGULATION INSTRUMENT
K760594 · JPA
Hematology · 78d
Cleared Oct 29, 1976
UNIFORM DROP SIZE PASTEUR TYPE PIPETS
K760719 · GJG
Hematology · 32d
Cleared Oct 08, 1976
PLATELET CONTROLS, NORMAL & ABNORMAL
K760549 · JPK
Hematology · 39d
Cleared Aug 03, 1976
ACTIN, ACTIVATED CEPHALOPLASTIN REAGENT
K760318 · GFO
Hematology · 8d
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