510(k) Report

Devices descending from K123050

2 later devices reach Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Hangzhou Clongene Biotech Co., Ltd.20191—
+2K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…Hangzhou Sejoy Electronics & Instruments Co., Ltd.20220—