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Biopool Intl., Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K002642
MINIQUANT D-DIMER, MODEL 1447
February 5, 2001
K983898
BIOCLOT APC SENSITIVITY
January 6, 1999
K981752
I-STAT COAGULATION CONTROL SET
June 15, 1998
K980314
FETAL D TECTION KIT
April 8, 1998