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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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