Medical Device Manufacturer · GB , Tyne And Wear

Immunodiagnostic Systems , Ltd.

23 submissions · 23 cleared · Since 1994
23
Total
23
Cleared
0
Denied

Immunodiagnostic Systems , Ltd. — FDA 510(k) Submissions

Immunodiagnostic Systems , Ltd. has submitted 23 FDA 510(k) premarket notifications since 1994, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Vitamin D, Single (specified) Analyte Controls (assayed And Unassayed), Radioimmunoassay, Parathyroid Hormone, Radioimmunoassay, Angiotensin I And Renin, Radioimmunoassay, Aldosterone . Use the specialty filter in the sidebar to narrow results.

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