QUANTA LITE SM ELISA

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 Lite Sm Elisa.

Pre-market Notification Details

Device IDK922831
510k NumberK922831
Device Name:QUANTA LITE SM ELISA
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego,  CA  92121
ContactBrys C Myers
CorrespondentBrys C Myers
INOVA DIAGNOSTICS, INC. 10451 ROSELLE ST. San Diego,  CA  92121
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-12
Decision Date1992-09-18

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