The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Epo Assay.
| Device ID | K052223 |
| 510k Number | K052223 |
| Device Name: | ACCESS EPO ASSAY |
| Classification | Assay, Erythropoietin |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Lynn Weist |
| Correspondent | Lynn Weist BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-15 |
| Decision Date | 2006-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590201845 | K052223 | 000 |
| 15099590201838 | K052223 | 000 |