QUANTA FLASH (TM) DGP SCREEN


Device Classification Name

antibodies, gliadin

510(k) Number K111414
Device Name QUANTA FLASH (TM) DGP SCREEN
Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

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

Correspodent Contact rufus burlingame
Regulation Number 866.5750
Classification Product Code
MST  
Subsequent Product Codes
JIX   JJX  
Date Received 05/20/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No