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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 K890319
Device Name URIC ACID KIT, CODES 4825400 AND 4825050
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact DIANNE EICH
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact DIANNE EICH
Regulation Number862.1775
Classification Product Code
KNK  
Date Received01/23/1989
Decision Date 04/12/1989
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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