510(k) Report

Devices descending from K970126

1 later device reach Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080166Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545Beckman Coulter, Inc.20080—