JFN · Atomic Absorption, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | JFN |
|---|---|
| Device Name | Atomic Absorption, 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 |
|---|---|---|---|---|
| K914510 | CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY | Beckman Instruments, Inc. | Nov 19, 1991 | SESE |
| K871903 | QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL) | Creative Scientific Technology, Inc. | Sep 2, 1987 | SESE |
| K770570 | CALCIUM/MAGNESIUM ANALYZER | Beckman Instruments, Inc. | Jun 8, 1977 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 2 clearances
- Creative Scientific Technology, Inc. — 1 clearance
