510(k) clearance
Elecsys EBV EBNA IgG
- 510(k) number
- K260221
- Applicant
- Roche Diagnostics
- Decision date
- Oct 2, 2026
- Date received
- Jan 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LSE
- Device type
- Epstein-Barr Virus, Other
- Device class
- Class I
- Regulation
- 21 CFR 866.3235
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Indianapolis, IN, US