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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 K970695
Device Name ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER ANTIGEN 27.29)
Applicant
CHIRON DIAGNOSTICS CORP.
1401 HARBOR BAY PKWY.
ALAMEDA,  CA  94501
Applicant Contact DIANE C OATES
Correspondent
CHIRON DIAGNOSTICS CORP.
1401 HARBOR BAY PKWY.
ALAMEDA,  CA  94501
Correspondent Contact DIANE C OATES
Regulation Number866.6010
Classification Product Code
MOI  
Date Received02/25/1997
Decision Date 08/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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