Antisera, Fluorescent, Chlamydia Spp.
FDA product code LKI · Class I (low risk) · 21 CFR 866.3120 · Microbiology
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914953 | Ifa for Chlamydia Trachomatis Igg AntibodyLKI · Traditional | Stellar Bio Systems, Inc. | 02/19/1992SE |
| K905531 | Lupus(Le)-Latex TestLKI · Traditional | Immco Diagnostics, Inc. | 01/25/1991SE |
| K894625 | Chlamydia (LGV-1)LKI · Traditional | Bion Ent., Ltd. | 08/15/1989SE |
| K883776 | BTC Chlamydia Direct Specimen Test & Control SlideLKI · Traditional | Btc Corp. | 02/03/1989SE |
| K854615 | Monabrite Chlamydia Trach Culture Confirmation TesLKI · Traditional | Serono Diagnostics, Inc. | 01/28/1986SE |
| K830342 | Culuture Set Chlamydia Isolation andLKI · Traditional | Immulok, Inc. | 05/04/1983SE |