Device Classification Name |
assay, erythropoietin
|
510(k) Number |
K240182 |
Device Name |
Access EPO |
Applicant |
Beckman Coulter Inc |
1000 Lake Hazeltine Drive |
Chaska,
MN
55318
|
|
Applicant Contact |
Kate Oelberg |
Correspondent |
Beckman Coulter Inc |
1000 Lake Hazeltine Drive |
Chaska,
MN
55318
|
|
Correspondent Contact |
Kate Oelberg |
Regulation Number | 864.7250
|
Classification Product Code |
|
Date Received | 01/23/2024 |
Decision Date | 04/22/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|