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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K984014
Device Name SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Applicant Contact LUCINDA STOCKERT
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.,M/S W-104
Box 8000
Brea,  CA  92822
Correspondent Contact LUCINDA STOCKERT
Regulation Number862.1150
Classification Product Code
JIX  
Date Received11/11/1998
Decision Date 12/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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