QUANTA LITE H-TTG SCREEN

Autoantibodies, Endomysial(tissue Transglutaminase)

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite H-ttg Screen.

Pre-market Notification Details

Device IDK073145
510k NumberK073145
Device Name:QUANTA LITE H-TTG SCREEN
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactJoseph Phillips
CorrespondentJoseph Phillips
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
Product CodeMVM  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-08
Decision Date2008-02-12
Summary:summary

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