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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name L-Isocitrate And Nadp (U.V.), Isocitric Dehydrogenase
510(k) Number K770519
Device Name REAGENT SYSTEM 153-UV
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 Number862.1420
Classification Product Code
JKG  
Date Received03/18/1977
Decision Date 06/03/1977
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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