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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K955938
Device Name CREATININE 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 Number862.1225
Classification Product Code
CGX  
Date Received12/21/1995
Decision Date 03/12/1996
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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