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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K971505
Device Name SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Correspondent Contact SHERI HALL
Regulation Number862.1175
Classification Product Code
CHH  
Date Received04/25/1997
Decision Date 06/11/1997
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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