K183088 is an FDA 510(k) clearance for the ADVIA Centaur Erythropoietin (EPO) assay. This device is classified as a Assay, Erythropoietin (Class II - Special Controls, product code GGT).
Submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on August 2, 2019, 269 days after receiving the submission on November 6, 2018.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7250.
| 510(k) Number | K183088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2018 |
| Decision Date | August 02, 2019 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGT - Assay, Erythropoietin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7250 |