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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K910635
Device Name TOTAL BILIRUBIN REAGENT SET
Applicant
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Applicant Contact ALEJO V ROY
Correspondent
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Correspondent Contact ALEJO V ROY
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/12/1991
Decision Date 05/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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