CHW · Titrimetric With Edta And Indicator, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CHW |
|---|---|
| Device Name | Titrimetric With Edta And Indicator, 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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K192730 | CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV | Biosystems S.A. | Sep 9, 2020 | SESE |
| K113521 | CALCIUM GEN. 2 | Roche Diagnostics | May 8, 2012 | SESE |
| K781454 | LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA | Union Carbide Corp. | Sep 20, 1978 | SESE |
Top Applicants
- Union Carbide Corp. — 1 clearance
- Roche Diagnostics — 1 clearance
- Biosystems S.A. — 1 clearance
