| Device Type ID | 2942 |
| Device Name | Myoglobin, Antigen, Antiserum, Control |
| Regulation Description | Myoglobin Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DDR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2942 |
| Device | Myoglobin, Antigen, Antiserum, Control |
| Product Code | DDR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Myoglobin Immunological Test System. |
| CFR Regulation Number | 866.5680 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 2 |
Incorrect Or Inadequate Test Results | 1 |
High Test Results | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Sep-28-2016 |
| 3 | Tosoh Bioscience Inc | II | Jun-05-2018 |