JFO · Fluorometric, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | JFO |
|---|---|
| Device Name | Fluorometric, 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920974 | BACTIDROP ACRIDINE ORANGE | Remel Co. | Jun 19, 1992 | SESE |
Top Applicants
- Remel Co. — 1 clearance
