Elecsys CA 15-3 II— 510(k) K181492
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K181492 for Elecsys CA 15-3 II, Substantially Equivalent on 2018-06-22. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code MOI
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code MOI
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