510(k) Report

Devices descending from K951538

2 later devices reach Besure One-=Step Home Ovulation Predictor Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983113Besure Plus One-Step Home Ovulation Predictor KitSyntron Bioresearch, Inc.19981—
+2K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd.20000—