BIOCLOT APC SENSITIVITY

Test, Qualitative And Quantitative Factor Deficiency

BIOPOOL INTL., INC.

The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Bioclot Apc Sensitivity.

Pre-market Notification Details

Device IDK983898
510k NumberK983898
Device Name:BIOCLOT APC SENSITIVITY
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant BIOPOOL INTL., INC. 6025 NICOLLE ST. Ventura,  CA  93003
ContactMichael D Bick
CorrespondentMichael D Bick
BIOPOOL INTL., INC. 6025 NICOLLE ST. Ventura,  CA  93003
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-03
Decision Date1999-01-06

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