QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA


Device Classification Name

autoantibodies, anti-soluble liver antigen (sla), autoimmune hepatitis

510(k) Number K021482
Device Name QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
Original Applicant
INOVA DIAGNOSTICS, INC.
10180 scripps ranch blvd.
san diego, 
CA 
92131 -1234

Original Contact brys c myers
Regulation Number 866.5660
Classification Product Code
NIY  
Date Received 05/08/2002
Decision Date 07/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No