Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Immunodiagnostic Systems , Ltd. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
368 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202136 | IDS Cortisol | Immunodiagnostic Systems , Ltd. | 2021-04-13 | 256 | 0 |
| K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. | 2020-09-30 | 217 | 0 |
| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 | 143 | 0 |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | 2017-01-31 | 281 | 0 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | Immunodiagnostic Systems , Ltd. | 2016-11-15 | 133 | 0 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Prog | Immunodiagnostic Systems , Ltd. | 2016-05-17 | 29 | 0 |
| K142351 | 25-Hydroxy Vitamin Ds EIA | Immunodiagnostic Systems , Ltd. | 2015-08-25 | 368 | 0 |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and I | Immunodiagnostic Systems , Ltd. | 2015-04-21 | 187 | 0 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-03-30 | 131 | 0 |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITA | Immunodiagnostic Systems , Ltd. | 2014-12-19 | 290 | 0 |
| K123763 | IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL S | Immunodiagnostic Systems , Ltd. | 2013-12-24 | 382 | 0 |
| K123253 | IDS ISYS 1,25 DIHYDROXY VITAMIN D, IDS-ISYS, 1,25 DIHYDROXY | Immunodiagnostic Systems , Ltd. | 2013-06-18 | 244 | 0 |
| K122141 | IDS-ISYS IGF-I CALIBRATION VERIFIERS | Immunodiagnostic Systems , Ltd. | 2012-08-07 | 19 | 0 |
| K111938 | IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE | Immunodiagnostic Systems , Ltd. | 2012-02-14 | 221 | 0 |
| K103325 | IDS-ISYS INTACT PTH | Immunodiagnostic Systems , Ltd. | 2012-02-03 | 448 | 0 |
| K111650 | IDS-ISYS CTX-1 (CROSSLAPS) CALIBRATION VERIFIERS, IDS-ISYS 2 | Immunodiagnostic Systems , Ltd. | 2011-09-06 | 85 | 0 |
| K110412 | IDS-ISYS IFG-I CONTROL SET | Immunodiagnostic Systems , Ltd. | 2011-03-16 | 30 | 0 |
| K051110 | 1,25-DIHYDROXY VITAMIN D EIA | Immunodiagnostic Systems , Ltd. | 2005-07-06 | 65 | 0 |
| K042519 | GAMMA-B 1,25-DIHYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2004-12-01 | 76 | 0 |
| K021163 | OCTEIA 25-HYDROXY VITAMIN D | Immunodiagnostic Systems , Ltd. | 2002-05-10 | 29 | 2 |
| K991998 | GAMMA-B 25-HYDROXY VITAMIN D RIA | Immunodiagnostic Systems , Ltd. | 1999-09-17 | 95 | 0 |
| K950510 | OCTEIA IGF-1 KIT | Immunodiagnostic Systems , Ltd. | 1995-04-05 | 58 | 0 |
| K942369 | GAMMA-BCT INTACT PTH | Immunodiagnostic Systems , Ltd. | 1994-09-20 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda