CIA · Methylthymol Blue, Calcium
Clinical Chemistry · 21 CFR 862.1145 · Class 2
Overview
| Product Code | CIA |
|---|---|
| Device Name | Methylthymol Blue, 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K870369 | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | Trace Scientific , Ltd. | Aug 19, 1987 | SESE |
| K863059 | CALCIOMETER | J. D. Assoc. | Sep 26, 1986 | SESE |
| K822898 | DSL 1600 | Diagnostic Systems Laboratories, Inc. | Dec 9, 1982 | SESE |
| K792396 | ELVI CALCIUM | Volu Sol Medical Industries | Dec 6, 1979 | SESE |
| K771468 | MULTISTAT III CALCIUM TEST | Instrumentation Laboratory CO | Sep 12, 1977 | SESE |
Top Applicants
- Diagnostic Systems Laboratories, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- J. D. Assoc. — 1 clearance
- Trace Scientific , Ltd. — 1 clearance
- Volu Sol Medical Industries — 1 clearance
