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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K071283
Device Name SYNCHRON SYSTEMS CREATININE REAGENT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
M/S W-110
Brea,  CA  92822 -8000
Applicant Contact TARA M VIVIANI
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd.
M/S W-110
Brea,  CA  92822 -8000
Correspondent Contact TARA M VIVIANI
Regulation Number862.1225
Classification Product Code
CGX  
Date Received05/07/2007
Decision Date 06/01/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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