FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
IDS-iSYS Total Testosterone
K Number: K252728
·
Decision Apr 15, 2026
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
3
Review Days
230
Basic Information
- Device Name
- IDS-iSYS Total Testosterone
- K Number
- K252728
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immunodiagnostic Systems Limited
- Date Received
- August 28, 2025
- Decision Date
- April 15, 2026
- Product Code
- CDZ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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