| Device Type ID | 345 |
| Device Name | Radioimmunoassay, Androstenedione |
| Regulation Description | Androstenedione 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) Exempt |
| CFR Regulation Number | 862.1075 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CIZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 345 |
| Device | Radioimmunoassay, Androstenedione |
| Product Code | CIZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Androstenedione Test System. |
| CFR Regulation Number | 862.1075 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
High Test Results | 1 |
False Negative Result | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics | II | Apr-30-2014 |
| 2 | Siemens Healthcare Diagnostics Inc. | II | Jul-15-2014 |