The following data is part of a premarket notification filed by Amgen, Inc. with the FDA for Erythropoietin Enzyme Immunoassay.
| Device ID | K882686 |
| 510k Number | K882686 |
| Device Name: | ERYTHROPOIETIN ENZYME IMMUNOASSAY |
| Classification | Assay, Erythropoietin |
| Applicant | AMGEN, INC. 1840 DE HAVILLAND Thousand Oaks, CA 91320 -1789 |
| Contact | Sarah C Swanson |
| Correspondent | Sarah C Swanson AMGEN, INC. 1840 DE HAVILLAND Thousand Oaks, CA 91320 -1789 |
| Product Code | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-30 |
| Decision Date | 1988-12-20 |