K252728
- 510(k) number
- K252728
- Device name
- IDS-iSYS Total Testosterone
- Applicant
- Immunodiagnostic Systems Limited GB
- Product code
- CDZ — Radioimmunoassay, Testosterones And Dihydrotestoster
- Decision date
- 2026-04-15
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252728.pdf
Official FDA record: K252728
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.