MODIFIED PATHFINDER SPECIMEN COLLECTION KIT

MODIFIED PATHFINDER SPECIMEN COLLECTION KIT is an FDA 510(k)-cleared medical device (K870963) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 7, 1987. Regulation: 8.