510(k) K983860

MTM BIOSCANNER K TEST STRIPS, CAT # BSA610 by Polymer Technology Systems, Inc. — Product Code JMK

K983860 is an FDA 510(k) premarket notification submitted by Polymer Technology Systems, Inc. for the device "MTM BIOSCANNER K TEST STRIPS, CAT # BSA610". The FDA issued a decision of Substantially Equivalent on December 27, 1999. The device falls under product code JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase), a Class I device regulated under 21 CFR 862.1380. Polymer Technology Systems, Inc. has at least 10 other 510(k) clearances on record.