Total clearances
5
2020-09-30 → 2026-04-15
Name variants in FDA filings: Immunodiagnostic Systems , Ltd. / Immunodiagnostic Systems Limited
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| CDZ |
Radioimmunoassay, Testosterones And Dihydrotestosterone |
Class I |
Clinical Chemistry |
2 |
2026-04-15 |
| CKG |
Radioimmunoassay, Acth |
Class II |
Clinical Chemistry |
1 |
2023-08-18 |
| CGR |
Radioimmunoassay, Cortisol |
Class II |
Clinical Chemistry |
1 |
2021-04-13 |
| CIN |
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
Class II |
Clinical Chemistry |
1 |
2020-09-30 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-04-15 |
K252728 |
IDS-iSYS Total Testosterone |
CDZ |
Class I |
Clinical Chemistry |
| 2024-10-23 |
K240865 |
IDS-iSYS Free Testosterone |
CDZ |
Class I |
Clinical Chemistry |
| 2023-08-18 |
K223867 |
IDS ACTH II |
CKG |
Class II |
Clinical Chemistry |
| 2021-04-13 |
K202136 |
IDS Cortisol |
CGR |
Class II |
Clinical Chemistry |
| 2020-09-30 |
K200475 |
IDS-iSYS Ostase BAP |
CIN |
Class II |
Clinical Chemistry |