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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
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