Antigen, Cf, Aspergillus Spp.
FDA product code JWT · Class I (low risk) · 21 CFR 866.3040 · Microbiology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812740 | Reagents for Serodiagnosis of AspergillJWT · Traditional | Nolan Biological Laboratories, Inc. | 10/20/1981SE |
| K792700 | Aspergillus SP, Complement FixationJWT · Traditional | Meridian Diagnostics, Inc. | 01/17/1980SE |
| K791387 | Aspergillus Mycelial Antigen #CF10024XJWT · Traditional | Immuno-Mycologics, Inc. | 08/16/1979SE |
| K790672 | Aspergillus Fumigatus, Aspergillus FlavuJWT · Traditional | Diagnostica, Inc. | 05/31/1979SE |
| K760830 | Aspergillus Mycelial AntigenJWT · Traditional | I M, Inc. | 11/01/1976SE |