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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K971309
Device Name UREA
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 Number862.1770
Classification Product Code
CDQ  
Date Received04/08/1997
Decision Date 08/01/1997
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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