Immunodiagnostic Systems , Ltd.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Immunodiagnostic Systems , Ltd.” (first 1994, latest 2021), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 138 days. Since 2017 the median was 236 days, against 151 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 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Immunodiagnostic Systems , Ltd. took a median 236 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MRG | System, Test, Vitamin D | 9 | 9 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 6 | 6 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 3 | 3 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| 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 |
Review panels
- Clinical Chemistry (24)
Most recent Immunodiagnostic Systems , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 |
| K142994 | IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers | CJM | 2015-04-21 | 187 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | JJX | 2015-03-30 | 131 |
| K140554 | IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET | MRG | 2014-12-19 | 290 |
14 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.
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 Limited (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Immunodiagnostic Systems , Ltd.?
FDA lists 24 510(k) clearances under the applicant name “Immunodiagnostic Systems , Ltd.” (first 1994, latest 2021), across 9 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 138 days. Since 2017: 236 days, versus 151 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, 9); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 6); CEW (Radioimmunoassay, Parathyroid Hormone, 3).
Next steps
- See all 24 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.