Elecsys Testosterone II— 510(k) K211685
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K211685 for Elecsys Testosterone II, Substantially Equivalent on 2022-05-06. Applicant: Roche Diagnostics. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CDZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1680
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code CDZ
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