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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 K984402
Device Name SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact LUCINDA STOCKERT
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact LUCINDA STOCKERT
Regulation Number862.1065
Classification Product Code
JIF  
Date Received12/09/1998
Decision Date 01/29/1999
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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