STA LIATEST FREE PS

Test, Qualitative And Quantitative Factor Deficiency

DIAGNOSTICA STAGO, INC.

The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta Liatest Free Ps.

Pre-market Notification Details

Device IDK092170
510k NumberK092170
Device Name:STA LIATEST FREE PS
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany,  NJ  07054
ContactUmberto V Parrotta
CorrespondentUmberto V Parrotta
DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany,  NJ  07054
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-21
Decision Date2009-12-22
Summary:summary

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