Elecsys Anti-SARS-CoV-2— 510(k) K250768
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K250768 for Elecsys Anti-SARS-CoV-2, Substantially Equivalent on 2025-06-10. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code QVP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3983
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
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