510(k) Report

Devices descending from K132085

2 later devices reach One Step HCG Test Strip, One Step HCG Test Cassette, One Step HCG Test Midstream through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One…Co-Innovation Biotech Co., Ltd.20220—
+1K183097Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step…Weihai Kangzhou Biotechnology Engineering Co., Ltd.20190—