| Device Type ID | 290 |
| Device Name | Radioimmunoassay, Prolactin (lactogen) |
| Regulation Description | Prolactin (lactogen) 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 | 862.1625 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CFT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 290 |
| Device | Radioimmunoassay, Prolactin (lactogen) |
| Product Code | CFT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Prolactin (lactogen) Test System. |
| CFR Regulation Number | 862.1625 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 26 |
Low Test Results | 6 |
Incorrect Or Inadequate Test Results | 5 |
Mechanical Problem | 2 |
Separation Failure | 1 |
| Total Device Problems | 40 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho Clinical Diagnostics Inc | II | Oct-03-2018 |
| 2 | Siemens Healthcare Diagnostics, Inc. | II | May-05-2017 |
| 3 | Tosoh Bioscience Inc | II | Jun-05-2018 |