QUANTA FLASH H-TTG IGA

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 Flash H-ttg Iga.

Pre-market Notification Details

Device IDK094060
510k NumberK094060
Device Name:QUANTA FLASH H-TTG IGA
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactTana Keivens
CorrespondentTana Keivens
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
Product CodeMVM  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-31
Decision Date2010-10-13

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