QUANTA LITE TPO 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 Tpo Elisa.

Pre-market Notification Details

Device IDK981857
510k NumberK981857
Device Name:QUANTA LITE TPO ELISA
ClassificationExtractable Antinuclear Antibody, Antigen And 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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-27
Decision Date1998-07-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950454458 K981857 000

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