Immunodiagnostic Systems , Ltd. - FDA 510(k) Cleared Devices
Recent clearances: IDS Cortisol, IDS-iSYS Ostase BAP, IDS SHBG
23
Total
23
Cleared
0
Denied
FDA 510(k) Regulatory Record - Immunodiagnostic Systems , Ltd. Chemistry ✕
23 devices
Cleared
Apr 13, 2021
IDS Cortisol
Chemistry
256d
Cleared
Sep 30, 2020
IDS-iSYS Ostase BAP
Chemistry
217d
Cleared
Jun 17, 2019
IDS SHBG
Chemistry
143d
Cleared
Jan 31, 2017
IDS-iSYS Intact PTHN
Chemistry
281d
Cleared
Nov 15, 2016
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
Chemistry
133d
Cleared
May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone...
Chemistry
29d
Cleared
Aug 25, 2015
25-Hydroxy Vitamin Ds EIA
Chemistry
368d
Cleared
Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS...
Chemistry
187d
Cleared
Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
Chemistry
131d
Cleared
Dec 19, 2014
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
Chemistry
290d
Cleared
Dec 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS...
Chemistry
382d
Cleared
Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL...
Chemistry
244d