| Device Type ID | 503 |
| Device Name | Radioimmunoassay, Progesterone |
| Regulation Description | Progesterone 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 | 862.1620 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JLS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 503 |
| Device | Radioimmunoassay, Progesterone |
| Product Code | JLS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Progesterone Test System. |
| CFR Regulation Number | 862.1620 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 8 |
High Test Results | 3 |
Low Test Results | 2 |
Unable To Obtain Readings | 1 |
Device Damaged Prior To Use | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Ireland Diagnostics Division | II | Dec-22-2018 |
| 2 | Arrow International Inc | II | Apr-10-2018 |
| 3 | Siemens Healthcare Diagnostics, Inc | II | Mar-09-2017 |
| 4 | Siemens Healthcare Diagnostics, Inc | II | Mar-02-2015 |
| 5 | Tosoh Bioscience Inc | II | Jun-05-2018 |
| 6 | Tosoh Bioscience Inc | II | Mar-01-2018 |