| Device Type ID | 285 |
| Device Name | Radioimmunoassay, Human Growth Hormone |
| Regulation Description | Human Growth 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 | 862.1370 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CFL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 285 |
| Device | Radioimmunoassay, Human Growth Hormone |
| Product Code | CFL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Human Growth Hormone Test System. |
| CFR Regulation Number | 862.1370 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Insufficient Information | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Sep-16-2016 |
| 2 | Tosoh Bioscience Inc | II | Jun-05-2018 |