MINIQUANT D-DIMER, MODEL 1447

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

BIOPOOL INTL., INC.

The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Miniquant D-dimer, Model 1447.

Pre-market Notification Details

Device IDK002642
510k NumberK002642
Device Name:MINIQUANT D-DIMER, MODEL 1447
ClassificationFibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
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 CodeDAP  
CFR Regulation Number864.7320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-24
Decision Date2001-02-05

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