510(k) Report

Devices descending from K935101

3 later devices reach Urine Calibrators and Controls Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032764Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)Lin-Zhi International, Inc.200311
+1K955676Synchron Systems Methaqualone ReagentBeckman Instruments, Inc.19960—
+2K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc.20040—