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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 K781720
Device Name HBDH ENZYME KINETIC REAGENT SET
Applicant
Medical Analysis Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Medical Analysis Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1380
Classification Product Code
JMK  
Date Received10/11/1978
Decision Date 11/03/1978
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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