510(k) K261109
- Device
- Access MeMed BV
- Applicant
- Beckman Coulter, Inc.
- 510(k) number
- K261109
- Product code
- QPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-19
- Date received
- 2026-04-03
- Regulation
- 866.3215
- Classification name
- Immunoassay For Host Biomarkers Of Infection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Christopher Fulmer
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2182595
- 3006165521
- 3011096386
- 3005269352