FETAL D TECTION KIT

Test, Screening, For D Positive Fetal Rbc's

BIOPOOL INTL., INC.

The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Fetal D Tection Kit.

Pre-market Notification Details

Device IDK980314
510k NumberK980314
Device Name:FETAL D TECTION KIT
ClassificationTest, Screening, For D Positive Fetal Rbc's
Applicant BIOPOOL INTL., INC. 1230 WILSON DR. West Chester,  PA  19380
ContactPeter L Minetti
CorrespondentPeter L Minetti
BIOPOOL INTL., INC. 1230 WILSON DR. West Chester,  PA  19380
Product CodeLIM  
CFR Regulation Number864.7455 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-27
Decision Date1998-04-08

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