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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrazone Colorimetry, Aldolase
510(k) Number K760821
Device Name REAGENT SYSTEM
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 Number862.1040
Classification Product Code
CJT  
Date Received10/13/1976
Decision Date 10/21/1976
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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