QUANTA FLASH (TM) DGP SCREEN

Antibodies, Gliadin

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Flash (tm) Dgp Screen.

Pre-market Notification Details

Device IDK111414
510k NumberK111414
Device Name:QUANTA FLASH (TM) DGP SCREEN
ClassificationAntibodies, Gliadin
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactRufus Burlingame
CorrespondentRufus Burlingame
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
Product CodeMST  
Subsequent Product CodeJIX
Subsequent Product CodeJJX
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-05-20
Decision Date2011-10-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950595731 K111414 000

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