QUANTA LITE F-ACTIN IGA ELISA


Device Classification Name

autoantibodies, endomysial(tissue transglutaminase)

510(k) Number K072967
Device Name QUANTA LITE F-ACTIN IGA ELISA
Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Applicant Contact brys c myers
Correspondent
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Correspodent Contact brys c myers
Regulation Number 866.5660
Classification Product Code
MVM  
Date Received 10/22/2007
Decision Date 01/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No