Antisera, Fluorescent, All Types, Staphylococcus Spp.
FDA product code GTN · Class I (low risk) · 21 CFR 866.3700 · Microbiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | Oxoid U.S.A., Inc. | 11/04/1986SE |
| K855233 | Diagnostic Reagent Set-RplaGTN · Traditional | Oxoid U.S.A., Inc. | 11/04/1986SE |
| K851949 | Staphaurex ZL30GTN · Traditional | Wellcome Diagnostics | 05/22/1985SE |
| K791453 | Agglutinotest-StaphylolisinGTN · Traditional | Volu Sol Medical Industries | 09/24/1979SE |