CID · Alizarin Sulfonate, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CID |
|---|---|
| Device Name | Alizarin Sulfonate, 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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870035 | KODAK EKTACHEM DT SLIDES (CA) | Eastman Kodak Company | May 12, 1987 | SESE |
| K801290 | ALIZARIN SULFONATE, CALCIUM | Union Carbide Corp. | Jun 30, 1980 | SESE |
Top Applicants
- Eastman Kodak Company — 1 clearance
- Union Carbide Corp. — 1 clearance
