| Device Type ID | 299 |
| Device Name | Radioimmunoassay, Follicle-stimulating Hormone |
| Regulation Description | Follicle-stimulating Hormone 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 | 862.1300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CGJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 299 |
| Device | Radioimmunoassay, Follicle-stimulating Hormone |
| Product Code | CGJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Follicle-stimulating Hormone Test System. |
| CFR Regulation Number | 862.1300 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Mechanical Problem | 3 |
Insufficient Information | 1 |
High Test Results | 1 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioMerieux SA | II | Jun-29-2018 |
| 2 | Ortho Clinical Diagnostics Inc | II | Oct-03-2018 |
| 3 | PerkinElmer Health Sciences, Inc. | III | Dec-16-2016 |
| 4 | Tosoh Bioscience Inc | II | Jun-05-2018 |