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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetry, Salicylate
510(k) Number K014173
Device Name SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact MARY BETH TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact MARY BETH TANG
Regulation Number862.3830
Classification Product Code
DKJ  
Date Received12/20/2001
Decision Date 02/15/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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