Antisera, Fluorescent, Poliovirus 1-3
FDA product code GOE · Class I (low risk) · 21 CFR 866.3405 · Microbiology
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940473 | Enterovirus 71 Monoclonal AntibodyGOE · Traditional | Chemicon Intl., Inc. | 09/12/1995SE |
| K940034 | Poliovirus 2 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/12/1995SE |
| K940027 | Enterovirus Blend Monoclonal AntibodiesGOE · Traditional | Chemicon Intl., Inc. | 09/12/1995SE |
| K940026 | Poliovirus Blend Monoclonal AntibodiesGOE · Traditional | Light Diagnostics | 09/12/1995SE |
| K940017 | Poliovirus 3 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/12/1995SE |
| K940363 | Enterovirus 70 Monclonal AntibodyGOE · Traditional | Light Diagnostics | 09/08/1995SE |
| K940018 | Poliovirus 1 Monoclonal AntibodyGOE · Traditional | Light Diagnostics | 09/08/1995SE |