FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
Device Facts
| Record ID | K002638 |
|---|---|
| Device Name | FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT |
| Applicant | Future Diagnostics B.V. |
| Product Code | CKG · Clinical Chemistry |
| Decision Date | Jan 17, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1025 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An adrenocorticotropic hormone (ACTH) test system is a device intended to measure adrenocorticotropic hormone in plasma and serum. ACTH measurements are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.
