Elecsys Anti-HAV IgM— 510(k) K260048
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K260048 for Elecsys Anti-HAV IgM, Substantially Equivalent on 2026-04-07. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code LOL
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.