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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase
510(k) Number K772033
Device Name GEMSAEC APPLI. FOR ULTRAZYME PLUS ALP*
Applicant
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HARLECO
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1380
Classification Product Code
JMK  
Date Received10/27/1977
Decision Date 11/17/1977
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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