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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K760885
Device Name KETOTROL-E
Original Applicant
SIGMA CHEMICAL CO.
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/22/1976
Decision Date 11/05/1976
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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