QUANTA LITE GP210 ELISA

Autoantibodies, Nuclear Pore Glycoprotein Gp210

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Gp210 Elisa.

Pre-market Notification Details

Device IDK040885
510k NumberK040885
Device Name:QUANTA LITE GP210 ELISA
ClassificationAutoantibodies, Nuclear Pore Glycoprotein Gp210
Applicant INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
ContactGary L Norman
CorrespondentGary L Norman
INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131
Product CodeNRI  
CFR Regulation Number866.5090 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-04-05
Decision Date2004-06-25

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