ANGIOTENSIN CONVERTING ENZYME ASSAY SYS
Device Facts
| Record ID | K791712 |
|---|---|
| Device Name | ANGIOTENSIN CONVERTING ENZYME ASSAY SYS |
| Applicant | Ventrex Laboratories, Inc. |
| Product Code | KQN · Clinical Chemistry |
| Decision Date | Sep 19, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1090 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
