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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 K830679
Device Name URIC ACID COLORIMETRIC DETERMINATION
Applicant
Dow Instruments & Reagents, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Dow Instruments & Reagents, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1775
Classification Product Code
KNK  
Date Received03/04/1983
Decision Date 04/06/1983
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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