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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Zimmerman/Norymberski, 17-Ketogenic Steroids
510(k) Number K760348
Device Name REAGENT SYSTEM, SIGMA PROCEDURE NO. 270
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 Number862.1385
Classification Product Code
CCZ  
Date Received08/02/1976
Decision Date 10/27/1976
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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