Immunodiagnostic Systems , Ltd. - FDA 510(k) Cleared Devices
23
Total
23
Cleared
0
Denied
FDA 510(k) cleared devices by 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
Cleared
Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
Chemistry
19d
Cleared
Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION...
Chemistry
221d
Cleared
Feb 03, 2012
IDS-ISYS INTACT PTH
Chemistry
448d
Cleared
Sep 06, 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN...
Chemistry
85d
Cleared
Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
Chemistry
30d
Cleared
Jul 06, 2005
1,25-DIHYDROXY VITAMIN D EIA
Chemistry
65d
Cleared
Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
Chemistry
76d
Cleared
May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
Chemistry
29d
Cleared
Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
Chemistry
95d
Cleared
Apr 05, 1995
OCTEIA IGF-1 KIT
Chemistry
58d
Cleared
Sep 20, 1994
GAMMA-BCT INTACT PTH
Chemistry
125d