| Device Type ID | 616 |
| Device Name | Bilirubin (total And Unbound) In The Neonate Test System |
| Regulation Description | Bilirubin (total And Unbound) In The Neonate Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1113 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | MQM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 616 |
| Device | Bilirubin (total And Unbound) In The Neonate Test System |
| Product Code | MQM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Bilirubin (total And Unbound) In The Neonate Test System. |
| CFR Regulation Number | 862.1113 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DRAEGER MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRAEGER MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOMETER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RADIOMETER MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Mechanical Problem | 14 |
Low Test Results | 11 |
Adverse Event Without Identified Device Or Use Problem | 8 |
High Test Results | 6 |
Low Readings | 3 |
Incorrect Or Inadequate Test Results | 2 |
Calibration Problem | 2 |
Probe | 2 |
Pump | 1 |
| Total Device Problems | 49 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Draeger Medical Systems, Inc. | I | Jun-07-2018 |
| 2 | Siemens Healthcare Diagnostics Inc | II | Mar-06-2015 |