ANGIOTENSIN CONVERTING ENZYME REA
Device Facts
| Record ID | K942497 |
|---|---|
| Device Name | ANGIOTENSIN CONVERTING ENZYME REA |
| Applicant | American Laboratory Products Co., Ltd. |
| Product Code | KQN · Clinical Chemistry |
| Decision Date | Nov 15, 1994 |
| 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.
