| Device Type ID | 3389 |
| Device Name | Reader, Zone, Automated |
| Regulation Description | Automated Zone Reader. |
| 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 | 866.2850 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KZK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 3389 |
| Device | Reader, Zone, Automated |
| Product Code | KZK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Automated Zone Reader. |
| CFR Regulation Number | 866.2850 [🔎] |