| Device Type ID | 443 |
| Device Name | Calibrator, Primary |
| Regulation Description | Calibrator. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JIS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 443 |
| Device | Calibrator, Primary |
| Product Code | JIS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Calibrator. |
| CFR Regulation Number | 862.1150 [🔎] |
| Device Problems | |
|---|---|
Calibration Problem | 2 |
High Test Results | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Nov-15-2016 |
| 2 | Ortho Clinical Diagnostics Inc | II | Feb-15-2019 |
| 3 | Siemens Healthcare Diagnostics, Inc. | III | Mar-15-2017 |