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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 K801243
Device Name COBAS REAGENTS FOR URIC ACID
Applicant
ROCHE ANALYTICAL INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROCHE ANALYTICAL INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1775
Classification Product Code
CDO  
Date Received05/27/1980
Decision Date 06/26/1980
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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