QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM


Device Classification Name

test system, antineutrophil cytoplasmic antibodies (anca)

510(k) Number K112545
Device Name QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
Applicant
INOVA DIAGNOSTICS, INC.
9900 old grove rd.
san diego, 
CA 
92131 -1638

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

Correspodent Contact michael mahler
Regulation Number 866.5660
Classification Product Code
MOB  
Subsequent Product Codes
JIX   JJX   MVJ  
Date Received 09/01/2011
Decision Date 07/31/2012
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