QUANTA PLEX CELIAC IGG PROFILE


Device Classification Name

autoantibodies, endomysial(tissue transglutaminase)

510(k) Number K072632
Device Name QUANTA PLEX CELIAC IGG PROFILE
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  
Subsequent Product Code
MST  
Date Received 09/18/2007
Decision Date 02/11/2008
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