CHZ · Di (O-Hydroxyphenylimine) Ethane, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CHZ |
|---|---|
| Device Name | Di (O-Hydroxyphenylimine) Ethane, Calcium |
| Regulation | 21 CFR 862.1145 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K840214 | CALCIUM REAGENT SYS | Sclavo, Inc. | Mar 19, 1984 | SESE |
Top Applicants
- Sclavo, Inc. — 1 clearance
