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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Immunological, Antigen, Tumor
510(k) Number K982680
Device Name CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
Applicant
Chiron Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Chiron Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number866.6010
Classification Product Code
MOI  
Date Received07/31/1998
Decision Date 10/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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