510(k) Report

Devices descending from K993317

4 later devices reach Acon HCG One Step Pregnancy Test Device (Urine) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123050Egens One Step HCG Urine Pregnancy Test Kit (S) (Strip, Cassette, Midstream I and…Nantong Biotechnology Co., Ltd.20132—
+1K102760Atlas Home Pregnancy Test (Midstream Format) Model 70172001Atlas Medical20110—
+2K193132CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…Hangzhou Clongene Biotech Co., Ltd.20191—
+3K212447SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette…Hangzhou Sejoy Electronics & Instruments Co., Ltd.20220—