IMUBIND PLASMA PAI-1 ELISA,MODEL 822

Test, Qualitative And Quantitative Factor Deficiency

AMERICAN DIAGNOSTICA, INC.

The following data is part of a premarket notification filed by American Diagnostica, Inc. with the FDA for Imubind Plasma Pai-1 Elisa,model 822.

Pre-market Notification Details

Device IDK013168
510k NumberK013168
Device Name:IMUBIND PLASMA PAI-1 ELISA,MODEL 822
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich,  CT  06830
ContactJohn B Berryman
CorrespondentJohn B Berryman
AMERICAN DIAGNOSTICA, INC. 222 RAILROAD AVE. Greenwich,  CT  06830
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-09-21
Decision Date2002-03-07
Summary:summary

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