510(k) Report

Devices descending from K152768

1 later device reach Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLC20250—