QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA

Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Asca (s. Cerevisiae) Iga Elisa.

Pre-market Notification Details

Device IDK000733
510k NumberK000733
Device Name:QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
ClassificationAntibodies, Saccharomyces Cerevisiae (s.cerevisiae)
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 CodeNBT  
CFR Regulation Number866.5785 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-06
Decision Date2001-05-21

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