QUANTA FLASH ENA7

Extractable Antinuclear Antibody, Antigen And Control

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash Ena7.

Pre-market Notification Details

Device IDK122923
510k NumberK122923
Device Name:QUANTA FLASH ENA7
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactMichael Mahler
CorrespondentMichael Mahler
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
Product CodeLLL  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-09-24
Decision Date2013-05-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950627821 K122923 000
08426950566397 K122923 000
08426950566380 K122923 000
08426950566373 K122923 000

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