510(k) Report

Devices descending from K890135

3 later devices reach Imx Follicle Stimulating Hormone (FSH) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032458Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx…Abbott Laboratories200322
+2K111023Abbott Architect LH CalibratorsAbbott Laboratories20111—
+3K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.20170—