NOVA LITE ENDOMYSIAL

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Nova Lite Endomysial.

Pre-market Notification Details

Device IDK980312
510k NumberK980312
Device Name:NOVA LITE ENDOMYSIAL
ClassificationMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
Applicant INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
ContactBrys C Myers
CorrespondentBrys C Myers
INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
Product CodeDBL  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-27
Decision Date1998-04-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.