ELECSYS TESTOSTERONE II IMMUNOASSAY— 510(k) K093421
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K093421 for ELECSYS TESTOSTERONE II IMMUNOASSAY, Substantially Equivalent on 2010-04-23. Applicant: Roche Diagnostics Corp.. Device class: 1.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- 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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