Glucolet Automatic Lancing Device for Obt. Blood

K855203 is the FDA 510(k) clearance record for GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD, a class II device, cleared for Miles Laboratories, Inc. on 1986-02-11 under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop...". FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from 1976-08-30 to 1988-05-26. As of 2026-09-10, FDA records show no recalls naming K855203.