510(k) K052223
- Device
- ACCESS EPO ASSAY
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K052223
- Product code
- GGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-10-06
- Date received
- 2005-08-15
- Regulation
- 864.7250
- Classification name
- Assay, Erythropoietin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN WEIST
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 8032314
- 3002800697
- 1222302
- 2432235
- 2182501
- 2245285
- 2025099
- 3002806944
- 2122870
Source Documents#
Legacy Summary#
summary
FDA Review#
Decision Summary