QUANTA Flash DsDNA, QUANTA Flash DsDNA Calibrators And QUANTA Flash DsDNA Controls

Anti-dna 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 Dsdna, Quanta Flash Dsdna Calibrators And Quanta Flash Dsdna Controls.

Pre-market Notification Details

Device IDK152013
510k NumberK152013
Device Name:QUANTA Flash DsDNA, QUANTA Flash DsDNA Calibrators And QUANTA Flash DsDNA Controls
ClassificationAnti-dna Antibody, Antigen And Control
Applicant INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego,  CA  92131
ContactGabriella Lakos
CorrespondentGabriella Lakos
INOVA DIAGNOSTICS, INC. 9900 OLD GROVE ROAD San Diego,  CA  92131
Product CodeLSW  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-21
Decision Date2016-04-11
Summary:summary

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