510(k) Report

Devices descending from K003858

1 later device reach Modification to at Home Drug Test, Models 9150, 9068, and 9175 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040629Accu-Stat Home Drug Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates…Accu-Stat Diagnostics, Inc.20040—