HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL

HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL is an FDA 510(k)-cleared medical device (K111999) manufactured by Healgen Scientific,, LLC. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2012. Regulation: 8.