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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 K934046
Device Name BECKMAN CHOLESTEROL REAGENT
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Correspondent Contact WILLIAM T RYAN
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Code
JIX  
Date Received08/19/1993
Decision Date 10/28/1993
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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