| Device Type ID | 374 |
| Device Name | Radioimmunoassay, Acth |
| Regulation Description | Adrenocorticotropic Hormone (ACTH) 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) |
| CFR Regulation Number | 862.1025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CKG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 374 |
| Device | Radioimmunoassay, Acth |
| Product Code | CKG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Adrenocorticotropic Hormone (ACTH) Test System. |
| CFR Regulation Number | 862.1025 [🔎] |
| Device Problems | |
|---|---|
High Test Results | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Low Test Results | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tosoh Bioscience Inc | II | Dec-22-2018 |