QUANTA LITE H-TTG SCREEN


Device Classification Name

autoantibodies, endomysial(tissue transglutaminase)

510(k) Number K073145
Device Name QUANTA LITE H-TTG SCREEN
Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Applicant Contact joseph phillips
Correspondent
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

Correspodent Contact joseph phillips
Regulation Number 866.5660
Classification Product Code
MVM  
Date Received 11/08/2007
Decision Date 02/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No