510(k) Report

Devices descending from K993203

2 later devices reach Acon One Step Pregnancy Test Strip (Urine) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112315Home Pregnancy TestNewscen Coast Bio-Pharmaceutical Co., Ltd.20120—
+1K070921Bionexia HCG Pregnancy Cassette and Dipstick Tests, Model 08-HCG and 02-HCGApplied Dna Technologies, Inc.20070—