Medical Device Manufacturer · US , Miami , FL

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

72 submissions · 72 cleared · Since 1988

Official Website

72

Total

72

Cleared

0

Denied

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

9 devices

1-9 of 9

Cleared Nov 22, 1994

DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA

Hematology · 385d

Cleared Nov 22, 1994

DADE INNOVIN II

Hematology · 357d

Cleared May 04, 1994

ANTITHROMBIN III CHROMOGENIC ASSAY

Hematology · 126d

Cleared Sep 22, 1993

DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI

Hematology · 84d

Cleared Jan 11, 1993

Hematology · 75d

Cleared Jul 27, 1992

DADE RECOMBOPLASTIN S

Hematology · 131d

Cleared Jun 04, 1992

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

Hematology · 99d

Cleared May 11, 1992

DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA

Hematology · 161d

Cleared Jan 15, 1992

DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY

Hematology · 82d