Medical Device Manufacturer · US , San Diego , CA

Biosite Incorporated - FDA 510(k) Cleared Devices

46 submissions · 45 cleared · Since 1990

46

Total

45

Cleared

1

Denied

FDA 510(k) Regulatory Record - Biosite Incorporated Hematology ✕

5 devices

1-5 of 5

Cleared Jun 11, 2010

INRATIO/INRATIO2 TEST STRIPS

Hematology · 256d

Cleared Mar 01, 2007

TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS

Hematology · 160d

Cleared Jan 29, 2007

TRIAGE PROTEIN C TEST

Hematology · 153d

Cleared Jun 29, 2005

TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS

Hematology · 91d

Cleared Nov 29, 2004

TRIAGE D-DIMER TEST, MODEL 98100

Hematology · 41d