510(k) K111999

HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL by Healgen Scientific,, LLC — Product Code JIO

K111999 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL". The FDA issued a decision of Substantially Equivalent on April 17, 2012. The device falls under product code JIO (Blood, Occult, Colorimetric, In Urine), a Class II device regulated under 21 CFR 864.6550. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.