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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Ammonia
510(k) Number K003196
Device Name SYNCHRON SYSTEMS AMMONIA REAGENT
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 Number862.1065
Classification Product Code
JIF  
Date Received10/12/2000
Decision Date 12/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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