IMMULITE 2000 ANTI-CCP IGG ASSAY


Device Classification Name

antibodies, anti-cyclic citrullinated peptide (ccp)

510(k) Number K121576
Device Name IMMULITE 2000 ANTI-CCP IGG ASSAY
Applicant
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Applicant Contact susan brocchi
Correspondent
Siemens Healthcare Diagnostics Inc.
511 benedict ave.
tarrytown, 
NY 
10591

Correspodent Contact susan brocchi
Regulation Number 866.5775
Classification Product Code
NHX  
Subsequent Product Code
JIT  
Date Received 05/30/2012
Decision Date 04/04/2013
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