Antigens, Cf, All, Mycoplasma Spp.
FDA product code GSB · Class I (low risk) · 21 CFR 866.3375 · Microbiology
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852933 | Mycoplasma SPP Serological ReagentsGSB · Traditional | Microbix Biosystems, Inc. | 08/01/1985SE |
| K843664 | Mycoplasma PneumoniaeGSB · Traditional | Institute Virion , Ltd. | 10/25/1984SE |
| K834338 | Mycoplasma Pneumoniae CF AntigenGSB · Traditional | Hillcrest Biologicals | 02/27/1984SE |
| K832132 | Sera-Tek Mycoplasma Antibody TestGSB · Traditional | Miles Laboratories, Inc. | 09/20/1983SE |
| K802934 | Mycoplasma Pneumoniae Antigen & ControlGSB · Traditional | Orion Diagnostica, Inc. | 12/31/1980SE |