FDA 510(k) Applications Submitted by Mick Henderson

FDA 510(k) Number Submission Date Device Name Applicant
K190121 01/25/2019 IDS SHBG Immunodiagnostic Systems Ltd.
K200475 02/26/2020 IDS-iSYS Ostase BAP Immunodiagnostic Systems Ltd.
K140554 03/04/2014 IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET IMMUNODIAGNOSTIC SYSTEMS LTD.
K161082 04/18/2016 IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers IMMUNODIAGNOSTIC SYSTEMS LTD.
K161831 07/05/2016 IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set Immunodiagnostic Systems Ltd
K202136 07/31/2020 IDS Cortisol Immunodiagnostic Systems Ltd.
K142351 08/22/2014 25-Hydroxy Vitamin Ds EIA IMMUNODIAGNOSTIC SYSTEMS LTD.
K223867 12/23/2022 IDS ACTH II Immunodiagnostic Systems Limited


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