PATHFINDER(TM) SPECIMEN COLLECTION KIT

PATHFINDER(TM) SPECIMEN COLLECTION KIT is an FDA 510(k)-cleared medical device (K863682) manufactured by Kallestad Laboratories, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 9, 1986. Regulation: 8.