510(k) K191832

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) by Kurin, Inc. — Product Code JKA

K191832 is an FDA 510(k) premarket notification submitted by Kurin, Inc. for the device "Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)". The FDA issued a decision of Substantially Equivalent on Feb 4, 2020. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Kurin, Inc. has 2 other 510(k) clearances on record.