FDA 510(k) Applications Submitted by MICK FENTON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K110412 |
02/14/2011 |
IDS-ISYS IFG-I CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
| K180509 |
02/27/2018 |
Quo-Test A1c System |
EKF-diagnostic GmbH |
| 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. |
| K172173 |
07/19/2017 |
DiaSpect Tm, DiaSpect Tm Cuvettes |
EKF-diagnostic GmbH |
| 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. |
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