QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA

Antibodies, Saccharomyces Cerevisiae (s.cerevisiae)

INOVA DIAGNOSTICS, INC.

The following data is part of a De Novo classification by Inova Diagnostics, Inc. with the FDA for Quanta Lite Asca (s. Cerevisiae) Igg Elisa.

Pre-market Notification Details

DeNovo IDDEN000007
Device Name:QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
ClassificationAntibodies, Saccharomyces Cerevisiae (s.cerevisiae)
Applicant INOVA DIAGNOSTICS, INC. 10180 Scripps Ranch Blvd. San Diego,  CA  92131
ContactBrys C Myers
Product CodeNBT  
CFR Regulation Number866.5785 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK000732
Review Advisory BoardImmunology
Classification AdvisoryImmunology
TypePost-NSE
Date Received2000-07-18
Decision Date2000-08-16
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