510(k) K240182
- Device
- Access EPO
- Applicant
- Beckman Coulter, Inc.
- 510(k) number
- K240182
- Product code
- GGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-22
- Date received
- 2024-01-23
- Regulation
- 864.7250
- Classification name
- Assay, Erythropoietin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kate Oelberg
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2025099
- 3002800697
- 2182501
- 1222302
- 8032314
- 3002806944
- 2245285
- 2122870
- 2432235