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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 K905790
Device Name TOTAL PROTEIN REAGENT SET
Applicant
BIOCHEMICAL TRADE, INC.
7522 N.W. 55TH ST.
MIAMI,  FL  33166
Applicant Contact ALEJO V ROY
Correspondent
BIOCHEMICAL TRADE, INC.
7522 N.W. 55TH ST.
MIAMI,  FL  33166
Correspondent Contact ALEJO V ROY
Regulation Number862.1635
Classification Product Code
CEK  
Date Received12/27/1990
Decision Date 02/21/1991
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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