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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name berthelot indophenol, urea nitrogen
510(k) Number K871651
Device Name COLORIMETRIC BUN REAGENT KIT
Applicant
BIOCHEMICAL TRADE, INC.
P.O. BOX 520575
MIAMI,  FL  33152
Applicant Contact ROY, PH.D.
Correspondent
BIOCHEMICAL TRADE, INC.
P.O. BOX 520575
MIAMI,  FL  33152
Correspondent Contact ROY, PH.D.
Regulation Number862.1770
Classification Product Code
CDL  
Date Received04/28/1987
Decision Date 05/12/1987
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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