IDS-iSYS Total Testosterone
FDA 510(k) clearance K252728 · decided 2026-04-15
Clearance details
- K-number
- K252728
- Device name
- IDS-iSYS Total Testosterone
- Applicant
- Immunodiagnostic Systems Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-08-28
- Decision date
- 2026-04-15
- Days to decision
- 230 days
- Clearance type
- Traditional
- Product code
- CDZ
- Device class
- 1
- Regulation number
- 862.1680
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tyne & Wear, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.