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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Uric, Uricase (Colorimetric)
510(k) Number K821741
Device Name URICACID
Applicant
Biodynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biodynamics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1775
Classification Product Code
KNK  
Date Received06/14/1982
Decision Date 07/02/1982
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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