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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 K842103
Device Name TOYO JOZO URIC ACID TEST
Applicant
Advocacy International, Ltd.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Advocacy International, Ltd.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number862.1775
Classification Product Code
KNK  
Date Received05/25/1984
Decision Date 08/12/1984
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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