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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 K971418
FOIA Releasable 510(k) K971418
Device Name CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) CENTAUR ANALYZER
Applicant
CHIRON DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Applicant Contact William J Pignato
Correspondent
CHIRON DIAGNOSTICS CORP.
63 NORTH ST.
MEDFIELD,  MA  02052
Correspondent Contact William J Pignato
Regulation Number866.6010
Classification Product Code
MOI  
Date Received04/16/1997
Decision Date 07/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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