| Device Type ID | 6077 |
| Device Name | Calibrators, Drug Specific |
| Regulation Description | Clinical Toxicology Calibrator. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.3200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DLJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 6077 |
| Device | Calibrators, Drug Specific |
| Product Code | DLJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Clinical Toxicology Calibrator. |
| CFR Regulation Number | 862.3200 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Lin-Zhi International Inc | II | Mar-12-2014 |