Aptiva Celiac Disease IgG 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 Igg Reagent.

Pre-market Notification Details

Device IDK200230
510k NumberK200230
Device Name:Aptiva Celiac Disease IgG Reagent
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant Inova Diagnostics, Inc. 9900 Old Grove Rd. San Diego,  CA  92131 -1638
ContactAndrea Seaman
CorrespondentAndrea Seaman
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 Received2020-01-30
Decision Date2021-08-26

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