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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 (u.v.)
510(k) Number K844986
Device Name ROCHE REAGENTS REAGENT FOR URIC ACID
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
DIV. OF HOFFMANN-LA ROCHE, INC
NUTLEY,  NJ  07110
Applicant Contact GRIFFIN FITZGERALD
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
DIV. OF HOFFMANN-LA ROCHE, INC
NUTLEY,  NJ  07110
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.1775
Classification Product Code
CDO  
Date Received12/26/1984
Decision Date 01/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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