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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
510(k) Number K830340
Device Name FITKIT I CHECKUP KIT
Applicant
BODITESTOR
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BODITESTOR
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1785
Classification Product Code
CDM  
Date Received02/02/1983
Decision Date 08/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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