FDA 510(k) Applications for Medical Device Product Code "JMK"
(Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase)

FDA 510(k) Number Applicant Device Name Decision Date
K953452 IHARA MEDICS U.S., INC. KETOREX C SANWA 05/02/1996
K981865 POLYMER TECHNOLOGY SYSTEMS, INC. MTM BIOSCANNER K TEST STRIPS 02/26/1999
K983860 POLYMER TECHNOLOGY SYSTEMS, INC. MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 12/27/1999


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