ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT
Device Facts
| Record ID | K926396 |
|---|---|
| Device Name | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT |
| Applicant | Nichols Institute |
| Product Code | CKG · Clinical Chemistry |
| Decision Date | Jul 27, 1993 |
| 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.
