QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA

Antibodies, Anti-actin, Anti-smooth Muscle

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Actin (anti-smooth Muscle) Elisa.

Pre-market Notification Details

Device IDK021648
510k NumberK021648
Device Name:QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
ClassificationAntibodies, Anti-actin, Anti-smooth Muscle
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 CodeNJF  
CFR Regulation Number866.5120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-20
Decision Date2002-09-20

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