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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
510(k) Number K041643
Device Name SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact MARY BETH TANG
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact MARY BETH TANG
Regulation Number862.1580
Classification Product Code
CEO  
Date Received06/17/2004
Decision Date 08/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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