510(k) Report

Devices descending from K964900

3 later devices reach Rapid Drug Screen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K984525Rapid Drug Screen 5-Panel with Methamphetamine TestAmerican Bio Medica Corp.19992—
+2K993961Rapid Drug Screen 3-Panel Test for Cocaine, Marijuana (THC) (Cannabinoids) and Opiates…American Bio Medica Corp.20000—
+2K993796Rapid Drug Screen 5-Panel Drug Screening Test for Cocaine, Marijuana, Opiates…American Bio Medica Corp.19990—