QUANTA LITE M2 EP (MIT3) ELISA

Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite M2 Ep (mit3) Elisa.

Pre-market Notification Details

Device IDK052262
510k NumberK052262
Device Name:QUANTA LITE M2 EP (MIT3) ELISA
ClassificationAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
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 CodeDBM  
CFR Regulation Number866.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-19
Decision Date2005-10-27

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