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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinalysis Controls (Assayed And Unassayed)
510(k) Number K760863
Device Name PRODUCT #K3002 KETOTROL-N(URINE CONTROL)
Applicant
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sigma Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJW  
Date Received10/18/1976
Decision Date 11/02/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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