CIL · Cresol Red Colorimetry, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | CIL |
|---|---|
| Device Name | Cresol Red Colorimetry, Carbon-Dioxide |
| Regulation | 21 CFR 862.1160 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
| 3rd-Party Reviewable | Yes |
Identification
A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
Classification Rationale
Class II.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922953 | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | Em Diagnostic Systems, Inc. | Sep 9, 1992 | SESE |
| K895880 | PANCREATIC A-AMYLASE EPS | Boehringer Mannheim Corp. | Dec 19, 1989 | SESE |
| K833724 | ENZYMATIC CO2 | American Monitor Corp. | Dec 29, 1983 | SESE |
| K800111 | CO2 CONTENT | American Monitor Corp. | Feb 13, 1980 | SESE |
Top Applicants
- American Monitor Corp. — 2 clearances
- Boehringer Mannheim Corp. — 1 clearance
- Em Diagnostic Systems, Inc. — 1 clearance
