Immunodiagnostic Systems , Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “Immunodiagnostic Systems , Ltd.” (first 1994, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 165 days. Since 2017 the median was 230 days, against 155 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 221 |
| 2013 | 2 | 313 |
| 2014 | 1 | 290 |
| 2015 | 3 | 187 |
| 2016 | 2 | 81 |
| 2017 | 1 | 281 |
| 2018 | 0 | — |
| 2019 | 1 | 143 |
| 2020 | 1 | 217 |
| 2021 | 1 | 256 |
| 2022 | 0 | — |
| 2023 | 1 | 238 |
| 2024 | 1 | 209 |
| 2025 | 0 | — |
| 2026 | 1 | 230 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Immunodiagnostic Systems , Ltd. took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRG | System, Test, Vitamin D | 8 | 8 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 6 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 3 | 3 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 | 3 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 | 1 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 | 1 |
| CJM | Radioimmunoassay, Aldosterone | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
Review panels
- Clinical Chemistry (26)
Most recent Immunodiagnostic Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252728 | IDS-iSYS Total Testosterone | CDZ | 2026-04-15 | 230 |
| K240865 | IDS-iSYS Free Testosterone | CDZ | 2024-10-23 | 209 |
| K223867 | IDS ACTH II | CKG | 2023-08-18 | 238 |
| K202136 | IDS Cortisol | CGR | 2021-04-13 | 256 |
| K200475 | IDS-iSYS Ostase BAP | CIN | 2020-09-30 | 217 |
| K190121 | IDS SHBG | CDZ | 2019-06-17 | 143 |
| K161158 | IDS-iSYS Intact PTHN | CEW | 2017-01-31 | 281 |
| K161831 | IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set | MRG | 2016-11-15 | 133 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | JJX | 2016-05-17 | 29 |
| K142351 | 25-Hydroxy Vitamin Ds EIA | MRG | 2015-08-25 | 368 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Immunodiagnostic Systems , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Immunodiagnostic Systems , Ltd. (23)
- Immunodiagnostic Systems Limited (3)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Immunodiagnostic Systems, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immunodiagnostic Systems , Ltd.?
FDA lists 26 510(k) clearances under 2 spellings of the applicant name “Immunodiagnostic Systems , Ltd.” (first 1994, latest 2026), across 10 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Immunodiagnostic Systems , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Immunodiagnostic Systems , Ltd. is 165 days. Since 2017: 230 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Immunodiagnostic Systems , Ltd.?
The most frequent FDA product codes under this applicant name are MRG (System, Test, Vitamin D, 8); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 6); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 3).
Next steps
- See all 26 Immunodiagnostic Systems , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MRG, Immunodiagnostic Systems , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.