FDA 510(k) Applications Submitted by Immunodiagnostic Systems Ltd.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110412 |
02/14/2011 |
IDS-ISYS IFG-I CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K111650 |
06/13/2011 |
IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIERS, AND IDS-ISYS... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K111938 |
07/08/2011 |
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K122141 |
07/19/2012 |
IDS-ISYS IGF-I CALIBRATION VERIFIERS |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K142994 |
10/16/2014 |
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K123253 |
10/17/2012 |
IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 DIHYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K103325 |
11/12/2010 |
IDS-ISYS INTACT PTH |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K123763 |
12/07/2012 |
IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATION VERIFIERS |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| 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. |
| K202136 |
07/31/2020 |
IDS Cortisol |
Immunodiagnostic Systems Ltd. |
| K142351 |
08/22/2014 |
25-Hydroxy Vitamin Ds EIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K021163 |
04/11/2002 |
OCTEIA 25-HYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K051110 |
05/02/2005 |
1,25-DIHYDROXY VITAMIN D EIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K991998 |
06/14/1999 |
GAMMA-B 25-HYDROXY VITAMIN D RIA |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K042519 |
09/16/2004 |
GAMMA-B 1,25-DIHYDROXY VITAMIN D |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K143324 |
11/19/2014 |
IDS-iSYS CTX-I Calibration Verifiers |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
|
|
