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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K905619
Device Name CREATININE (RATE) REAGENT SET
Applicant
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Applicant Contact ALEJO ROY
Correspondent
Biochemical Trade, Inc.
7522 NW 55th St.
Miami,  FL  33166
Correspondent Contact ALEJO ROY
Regulation Number862.1225
Classification Product Code
CGX  
Date Received12/14/1990
Decision Date 02/13/1991
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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