Dna-Reagents, Campylobacter Spp.
FDA product code LQO · Class I (low risk) · 21 CFR 866.3110 · Microbiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K894712 | Accuprobe Campylobacter Culture ConfirmationLQO · Traditional | Gen-Probe, Inc. | 11/14/1989SE |
| K873670 | Snap Campylobactor Diagnostic KitLQO · Traditional | Molecular Biosystems, Inc. | 06/08/1988SE |
| K875101 | Virogen CMV Antibody TestLQO · Traditional | Wampole Laboratories | 03/01/1988SE |
| K863270 | Gene-Trak Campylobacter AssayLQO · Traditional | Integrated Genetics | 08/31/1987SE |