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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name C-Reactive Protein, Antigen, Antiserum, And Control
510(k) Number K963061
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Correspondent Contact ANNETTE HELLIE
Regulation Number866.5270
Classification Product Code
DCK  
Date Received08/07/1996
Decision Date 11/04/1996
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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