Medical Device Manufacturer · US , Ventura , CA

Biopool Intl., Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1998

Recent clearances: MINIQUANT D-DIMER, MODEL 1447, BIOCLOT APC SENSITIVITY, I-STAT COAGULATION CONTROL SET

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biopool Intl., Inc. Hematology ✕

4 devices

1-4 of 4

Cleared Feb 05, 2001

MINIQUANT D-DIMER, MODEL 1447

Hematology · 165d

Cleared Jan 06, 1999

BIOCLOT APC SENSITIVITY

Hematology · 64d

Cleared Jun 15, 1998

I-STAT COAGULATION CONTROL SET

Hematology · 28d

Cleared Apr 08, 1998

FETAL D TECTION KIT

Hematology · 71d