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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 K821799
Device Name FITKIT I CHECKUP KIT
Applicant
PATTON, BOGGS & BLOW
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PATTON, BOGGS & BLOW
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1785
Classification Product Code
CDM  
Date Received06/18/1982
Decision Date 08/16/1983
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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