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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K993023
Device Name SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
Applicant
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Applicant Contact GAIL L EFEBVRE
Correspondent
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
Correspondent Contact GAIL L EFEBVRE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/09/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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