| Device Type ID | 3361 |
| Device Name | Susceptibility Test Discs, Antimicrobial |
| Regulation Description | Antimicrobial Susceptibility Test Disc. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.1620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JTN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3361 |
| Device | Susceptibility Test Discs, Antimicrobial |
| Product Code | JTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antimicrobial Susceptibility Test Disc. |
| CFR Regulation Number | 866.1620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARDY DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Remel Inc | II | Dec-17-2015 |
| 2 | Remel Inc | II | Mar-20-2014 |
| 3 | Remel Inc | II | Jan-21-2014 |
| 4 | Remel Inc | II | Jan-14-2014 |