510(k) K902442

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

K902442 is an FDA 510(k) premarket notification submitted by Sudormed, Inc. for the device "SUDORMED SWEAT PATCH SPECIMEN CONTAINER". The FDA issued a decision of Substantially Equivalent on October 4, 1990. 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.