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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 K845052
Device Name PARAMAX TOTAL PROTEIN REAGENT TP
Applicant
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Applicant Contact JAMES E KELLER
Correspondent
AMERICAN DADE
P.O. BOX 25101
SANTA ANA,  CA  92799
Correspondent Contact JAMES E KELLER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received02/15/1984
Decision Date 04/13/1984
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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