510(k) Report

Devices descending from K004034

4 later devices reach Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052520Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for Amphetamine…Tianjin New Bay Bioresearch Co., Ltd.20060—
+1K052882Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup DeviceTianjin New Bay Bioresearch Co., Ltd.20062—
+2K071489Homecheck Multiple Drug Cup TestTianjin New Bay Bioresearch Co., Ltd.20080—
+2K061617Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd.20060—