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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, General Purpose, Hematology
510(k) Number K981592
Device Name ACS:CENTAUR AFP
Applicant
Chiron Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact THOMAS F FLYNN
Correspondent
Chiron Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact THOMAS F FLYNN
Regulation Number866.6010
Classification Product Code
LOQ  
Date Received05/04/1998
Decision Date 07/07/1998
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
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