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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 K812641
Device Name URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM
Applicant
Reagents Applications, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Reagents Applications, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1775
Classification Product Code
KNK  
Date Received09/16/1981
Decision Date 10/02/1981
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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