NOVA LITE(TM) ANA PLUS

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 Nova Lite(tm) Ana Plus.

Pre-market Notification Details

Device IDK881339
510k NumberK881339
Device Name:NOVA LITE(TM) ANA PLUS
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 Received1988-03-29
Decision Date1988-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950596387 K881339 000
08426950593539 K881339 000

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