Aptiva Celiac Disease IgA Reagent

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 Aptiva Celiac Disease Iga Reagent.

Pre-market Notification Details

Device IDK193604
510k NumberK193604
Device Name:Aptiva Celiac Disease IgA Reagent
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant Inova Diagnostics, Inc. 9900 Old Grove Road San Diego,  CA  92131 -1638
ContactAndrea Seaman
CorrespondentRonda Elliott
Inova Diagnostics, Inc. 9900 Old Grove Road San Diego,  CA  92131 -1638
Product CodeMVM  
Subsequent Product CodeMST
Subsequent Product CodeNSU
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-23
Decision Date2021-06-16

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