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 |