QUANTA LITE CELIAC 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 Lite Celiac Dgp Screen.

Pre-market Notification Details

Device IDK062708
510k NumberK062708
Device Name:QUANTA LITE CELIAC DGP SCREEN
ClassificationAntibodies, Gliadin
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
ContactDonna L Gustafson
CorrespondentDonna L Gustafson
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE RD. San Diego,  CA  92131 -1638
Product CodeMST  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-11
Decision Date2006-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950593324 K062708 000

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