The following data is part of a premarket notification filed by Amgen, Inc. with the FDA for Clinigen Erythropoietin Human Serum Controls 1,2,3.
| Device ID | K894943 |
| 510k Number | K894943 |
| Device Name: | CLINIGEN ERYTHROPOIETIN HUMAN SERUM CONTROLS 1,2,3 |
| Classification | Assay, Erythropoietin |
| Applicant | AMGEN, INC. 1840 DE HAVILLAND Thousand Oaks, CA 91320 -1789 |
| Contact | Sarah Swanson |
| Correspondent | Sarah 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 | 1989-08-03 |
| Decision Date | 1989-10-10 |