510(k) Report

Devices descending from K152269

1 later device reach Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC20170—