Hemopexin, Antigen, Antiserum, Control
FDA product code CZX · Class II (moderate risk) · 21 CFR 866.5490 · Immunology
3510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K801432 | Hemopexin Nephelometric AssayCZX · Traditional | J.T. Baker Chemical Co. | 07/08/1980SE |
| K790713 | Antiserum to Human HemopexinCZX · Traditional | Kent Laboratories, Inc. | 09/04/1979SE |
| K780250 | Hemopexin Nephelometric AssaysCZX · Traditional | Kallestad Laboratories, Inc. | 02/28/1978SE |