Medical Device Manufacturer · US , Mchenry , IL

Bio-Rad - FDA 510(k) Cleared Devices

319 submissions · 319 cleared · Since 1976

Official Website

319

Total

319

Cleared

0

Denied

FDA 510(k) Regulatory Record - Bio-Rad Hematology ✕

35 devices

1-12 of 35

Cleared Nov 05, 2004

LIQUICHEK RETICULOCYTE CONTROL (A)

Hematology · 22d

Cleared Jun 28, 2004

LIQUICHEK HEMATOLOGY CONTROL (A)

Hematology · 27d

Cleared Feb 27, 2004

LYPHOCHEK HEMOSTASIS CONTROL

Hematology · 22d

Cleared Sep 17, 2003

LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743

Hematology · 23d

Cleared Aug 08, 2003

LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3

Hematology · 39d

Cleared Feb 24, 2003

LIQUICHEK D-DIMER CONTROL, MODEL 356, 357

Hematology · 38d

Cleared Apr 15, 2002

LYPHOCHEK HEMOSTASIS, MODELS 798, 799

Hematology · 28d

Cleared Sep 18, 2001

LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2,...

Hematology · 34d

Cleared Dec 19, 2000

VARIANT II TOTAL GHB

Hematology · 61d

Cleared Nov 29, 2000

LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET

Hematology · 62d

Cleared Jun 10, 1999

VARIANT II B-THALASSEMIA

Hematology · 69d

Cleared Apr 21, 1999

LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789

Hematology · 37d