QUANTA LITE CCP3.1 IGG/IGA ELISA


Device Classification Name

antibodies, anti-cyclic citrullinated peptide (ccp)

510(k) Number K072944
Device Name QUANTA LITE CCP3.1 IGG/IGA ELISA
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 866.5775
Classification Product Code
NHX  
Date Received 10/17/2007
Decision Date 03/05/2008
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