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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biuret (colorimetric), total protein
510(k) Number K955936
Device Name TOTAL PROTEIN 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 Number862.1635
Classification Product Code
CEK  
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
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