SPECTROLYSE PAI-1, MODEL 101201

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 Spectrolyse Pai-1, Model 101201.

Pre-market Notification Details

Device IDK063323
510k NumberK063323
Device Name:SPECTROLYSE PAI-1, MODEL 101201
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford,  CT  06902
ContactDavid Teicher
CorrespondentDavid Teicher
AMERICAN DIAGNOSTICA, INC. 500 WEST AVENUE Stamford,  CT  06902
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-11-03
Decision Date2007-08-15
Summary:summary

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