510(k) K152269

Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) by Healgen Scientific,, LLC — Product Code DKZ

K152269 is an FDA 510(k) premarket notification submitted by Healgen Scientific,, LLC for the device "Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card)". The FDA issued a decision of Substantially Equivalent on September 9, 2015. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Healgen Scientific,, LLC has at least 10 other 510(k) clearances on record.