K052223 is an FDA 510(k) clearance for the ACCESS EPO ASSAY. This device is classified as a Assay, Erythropoietin (Class II - Special Controls, product code GGT).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on October 6, 2006, 417 days after receiving the submission on August 15, 2005.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7250.
| 510(k) Number | K052223 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2005 |
| Decision Date | October 06, 2006 |
| Days to Decision | 417 days |
| Submission Type | Abbreviated |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GGT — Assay, Erythropoietin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7250 |