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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 K980190
Device Name ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM)
Applicant
Chiron Corp.
4560 Horton St.
Emeryville,  CA  94608 -2916
Applicant Contact NANCY A HORNBAKER
Correspondent
Chiron Corp.
4560 Horton St.
Emeryville,  CA  94608 -2916
Correspondent Contact NANCY A HORNBAKER
Regulation Number866.6010
Classification Product Code
MOI  
Date Received01/20/1998
Decision Date 03/06/1998
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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