510(k) clearance
Access MeMed BV
- 510(k) number
- K261109
- Applicant
- Beckman Coulter, Inc.
- Decision date
- Oct 19, 2026
- Date received
- Apr 3, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- QPS
- Device type
- Immunoassay For Host Biomarkers Of Infection
- Device class
- Class II
- Regulation
- 21 CFR 866.3215
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Chaska, MN, US