510(k) Report

Devices descending from K903219

2 later devices reach Abbott Testpack Plus TM HCG-Combo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K980736Acon HCG One Step Urine/Serum Pregnancy TestAcon Laboratories Co.19981—
+2K072500One Step HCG Urine/Serum TestGuangzhou Wondfo Biotech Co., Ltd.20090—