Immunodiagnostic Systems, Inc.
Immunodiagnostic Systems, Inc. appears in FDA public data with 0 recalls, 24 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 13, 2021.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 24
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K202136 | IDS Cortisol | April 13, 2021 |
| K200475 | IDS-iSYS Ostase BAP | September 30, 2020 |
| K190121 | IDS SHBG | June 17, 2019 |
| K161158 | IDS-iSYS Intact PTHN | January 31, 2017 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | November 15, 2016 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | May 17, 2016 |
| K142351 | 25-Hydroxy Vitamin Ds EIA | August 25, 2015 |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifier | April 21, 2015 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | March 30, 2015 |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | December 19, 2014 |
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIRECT RENIN CALIBRATIO | December 24, 2013 |
| K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY VITAMIN D CONTROL SET, AND IDS ISYS 1,25 | June 18, 2013 |
| K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | August 7, 2012 |
| K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISY | February 14, 2012 |
| K103325 | IDS-ISYS INTACT PTH | February 3, 2012 |
| K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 25 HYDROXY VITAMIN D CALIBRATION VERIFIER | September 6, 2011 |
| K110412 | IDS-ISYS IFG-I CONTROL SET | March 16, 2011 |
| K091849 | IDS-ISYS 25-HYDROXY VITAMIN D ASSAY, IDS-ISYS 25-HYDROXY VITAMIN D CONTROL SET | June 25, 2010 |
| K051110 | 1,25-DIHYDROXY VITAMIN D EIA | July 6, 2005 |
| K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | December 1, 2004 |