Medical Device Manufacturer · GB , Tyne And Wear

Immunodiagnostic Systems , Ltd. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1994

Recent clearances: IDS Cortisol, IDS-iSYS Ostase BAP, IDS SHBG

23
Total
23
Cleared
0
Denied

Immunodiagnostic Systems , Ltd. has 23 FDA 510(k) cleared chemistry devices. Based in Tyne And Wear, GB.

Last cleared in 2021. Active since 1994.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Immunodiagnostic Systems , Ltd.

23 devices
1-23 of 23
Cleared Apr 13, 2021
IDS Cortisol
K202136 · CGR
Chemistry · 256d
Cleared Sep 30, 2020
IDS-iSYS Ostase BAP
K200475 · CIN
Chemistry · 217d
Cleared Jun 17, 2019
IDS SHBG
K190121 · CDZ
Chemistry · 143d
Cleared Jan 31, 2017
IDS-iSYS Intact PTHN
K161158 · CEW
Chemistry · 281d
Cleared Nov 15, 2016
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set
K161831 · MRG
Chemistry · 133d
Cleared May 17, 2016
IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone...
K161082 · JJX
Chemistry · 29d
Cleared Aug 25, 2015
25-Hydroxy Vitamin Ds EIA
K142351 · MRG
Chemistry · 368d
Cleared Apr 21, 2015
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS...
K142994 · CJM
Chemistry · 187d
Cleared Mar 30, 2015
IDS-iSYS CTX-I Calibration Verifiers
K143324 · JJX
Chemistry · 131d
Cleared Dec 19, 2014
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET
K140554 · MRG
Chemistry · 290d
Cleared Dec 24, 2013
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS...
K123763 · CIB
Chemistry · 382d
Cleared Jun 18, 2013
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL...
K123253 · MRG
Chemistry · 244d
Cleared Aug 07, 2012
IDS-ISYS IGF-I CALIBRATION VERIFIERS
K122141 · JJX
Chemistry · 19d
Cleared Feb 14, 2012
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION...
K111938 · JJX
Chemistry · 221d
Cleared Feb 03, 2012
IDS-ISYS INTACT PTH
K103325 · CEW
Chemistry · 448d
Cleared Sep 06, 2011
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN...
K111650 · JJX
Chemistry · 85d
Cleared Mar 16, 2011
IDS-ISYS IFG-I CONTROL SET
K110412 · JJX
Chemistry · 30d
Cleared Jul 06, 2005
1,25-DIHYDROXY VITAMIN D EIA
K051110 · MRG
Chemistry · 65d
Cleared Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · MRG
Chemistry · 76d
Cleared May 10, 2002
OCTEIA 25-HYDROXY VITAMIN D
K021163 · MRG
Chemistry · 29d
Cleared Sep 17, 1999
GAMMA-B 25-HYDROXY VITAMIN D RIA
K991998 · MRG
Chemistry · 95d
Cleared Apr 05, 1995
OCTEIA IGF-1 KIT
K950510 · CFL
Chemistry · 58d
Cleared Sep 20, 1994
GAMMA-BCT INTACT PTH
K942369 · CEW
Chemistry · 125d
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