Medical Device Manufacturer · US , Thousand Oaks , CA

Kamiya Biomedical Co. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1991

Recent clearances: K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL, K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR, K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SET

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kamiya Biomedical Co. Hematology ✕

5 devices

1-5 of 5

Cleared Jun 27, 2003

K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090

Hematology · 114d

Cleared Aug 21, 2001

K-ASSAY D-DIMER CONTROLS

Hematology · 22d

Cleared May 18, 2001

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

Hematology · 239d

Cleared Apr 26, 2000

Hematology · 82d

Cleared Dec 06, 1999

K-ASSAY FIBRINOGEN

Hematology · 53d