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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact SUSAN BROCCHI
Regulation Number866.5775
Classification Product Code
NHX  
Subsequent Product Code
JIT  
Date Received05/30/2012
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
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