510(k) Report

Devices descending from K001411

2 later devices reach Whole PTH (1-84) Specific Immunoradiometric Irma Diagnostic Assay Kit, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersDiaSorin, Inc.201511
+2K190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.20190—