510(k) Report

Devices descending from K973858

3 later devices reach Cards Q.S. HCG Serum/Urine;Concise Performance Plus HCG-Combo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…Assure Tech. Co., Ltd.20161—
+1K131166Sofia (R) HCG FiaQuidel Corp.20130—
+2K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC20250—