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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Myoglobin, Antigen, Antiserum, Control
510(k) Number K974325
Device Name CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
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 Number866.5680
Classification Product Code
DDR  
Date Received11/18/1997
Decision Date 12/08/1997
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
Predetermined Change
Control Plan Authorized		 No
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