QUANTA LITE F-ACTIN IGA ELISA

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 F-actin Iga Elisa.

Pre-market Notification Details

Device IDK072967
510k NumberK072967
Device Name:QUANTA LITE F-ACTIN IGA ELISA
ClassificationAutoantibodies, Endomysial(tissue Transglutaminase)
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactBrys C Myers
CorrespondentBrys C Myers
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 Received2007-10-22
Decision Date2008-01-28

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