Device, Antimicrobial Drug Removal
FDA product code LJF · Class I (low risk) · 21 CFR 866.2560 · Microbiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003104 | Bact/Alert CSRLJF · Traditional | Organon Teknika Corp. | 10/20/2000SE |
| K830372 | Artimicrobial Removal DeviceLJF · Traditional | Marion Laboratories, Inc. | 04/08/1983SE |
| K830363 | Bactec 170 Tryptic Soy Broth W/ResinsLJF · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 03/24/1983SE |
| K822344 | Antimicrobial Removal Device (Ard)LJF · Traditional | Marion Laboratories, Inc. | 08/25/1982SE |