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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 K990704
Device Name ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number866.5270
Classification Product Code
DCK  
Date Received03/04/1999
Decision Date 05/03/1999
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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