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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 K971072
Device Name CHOLESTEROL REAGENT
Applicant
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Applicant Contact CHARLES C ALLAIN
Correspondent
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Correspondent Contact CHARLES C ALLAIN
Regulation Number862.1175
Classification Product Code
CHH  
Date Received03/24/1997
Decision Date 06/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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