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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K843112
Device Name ROCHE STANDARDS FOR URIC ACID
Original Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/07/1984
Decision Date 09/13/1984
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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