QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA

Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis

INOVA DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Inova Diagnostics, Inc. with the FDA for Quanta Lite Sla (soluble Liver Antigen) Elisa.

Pre-market Notification Details

Device IDK021482
510k NumberK021482
Device Name:QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
ClassificationAutoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis
Applicant INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131 -1234
ContactBrys C Myers
CorrespondentBrys C Myers
INOVA DIAGNOSTICS, INC. 10180 SCRIPPS RANCH BLVD. San Diego,  CA  92131 -1234
Product CodeNIY  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-08
Decision Date2002-07-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950593706 K021482 000

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