510(k) Report

Devices descending from K002836

2 later devices reach Media for Gamete Preparation and Embryo Culture through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red…Origio A/S20180—
+1K053646Invitro Maturation MediaSage In-Vitro Fertilization, Inc.20060—