510(k) K926253

SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE by Sudormed, Inc. — Product Code JKA

K926253 is an FDA 510(k) premarket notification submitted by Sudormed, Inc. for the device "SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE". The FDA issued a decision of Substantially Equivalent on July 14, 1995. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sudormed, Inc. has at least 5 other 510(k) clearances on record.