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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 -8000
Applicant Contact LUCINDA STOCKERT
Correspondent
BECKMAN COULTER, INC.
200 S. KRAEMER BLVD.,M/S W-104
BOX 8000
BREA,  CA  92822 -8000
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
Recalls CDRH Recalls
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