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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nadh Oxidation/Nad Reduction, Alt/Sgpt
510(k) Number K965134
Device Name ALT/SGPT
Applicant
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Applicant Contact CHARLES C ALLAIN, PH.D.
Correspondent
Derma Media Lab., Inc.
8531 Wellsford Pl., Suite E
Santa Fe Springs,  CA  90670
Correspondent Contact CHARLES C ALLAIN, PH.D.
Regulation Number862.1030
Classification Product Code
CKA  
Date Received12/23/1996
Decision Date 02/18/1997
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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