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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 K820632
Device Name COLORIMETRIC URIC ACID REAGENT SET
Applicant
BIORENT DIAGNOSTIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
BIORENT DIAGNOSTIC, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1775
Classification Product Code
KNK  
Date Received03/08/1982
Decision Date 03/25/1982
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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