ROCHE DIAGNOSTICS ELECSYS AFP CALSET II— 510(k) K043095
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K043095 for ROCHE DIAGNOSTICS ELECSYS AFP CALSET II, Substantially Equivalent on 2004-11-23. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code JIT
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Recent devices under product code JIT
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