The following data is part of a premarket notification filed by Axis-shield Diagnostics Limited with the FDA for Advia Centaur Erythropoietin (epo) Assay.
| Device ID | K183088 |
| 510k Number | K183088 |
| Device Name: | ADVIA Centaur Erythropoietin (EPO) Assay |
| Classification | Assay, Erythropoietin |
| Applicant | Axis-Shield Diagnostics Limited Luna Place, The Technology Park Dundee, GB Dd2 1xa |
| Contact | Claire Dora |
| Correspondent | Claire Dora Axis-Shield Diagnostics Limited Luna Place, The Technology Park Dundee, GB Dd2 1xa |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-06 |
| Decision Date | 2019-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414245775 | K183088 | 000 |
| 00630414010380 | K183088 | 000 |