CHS · Coulometric Method, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | CHS |
|---|---|
| Device Name | Coulometric Method, 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.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Medical Analysis Systems, Inc. | Feb 3, 1993 | SESE |
| K911838 | ROCHE REAGENT FOR C02 | Roche Diagnostic Systems, Inc. | Jul 19, 1991 | SESE |
| K860660 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Amresco, Inc. | Mar 14, 1986 | SESE |
| K841080 | TECHNICON RA-1000 SYS CO2 | Technicon Instruments Corp. | May 2, 1984 | SESE |
| K811257 | CORNING 965 CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | May 27, 1981 | SESE |
| K802376 | KODAK EKTA-CHEM CLINICAL CHEM. SLIDES | Eastman Kodak Company | Oct 23, 1980 | SESE |
Top Applicants
- Technicon Instruments Corp. — 1 clearance
- Roche Diagnostic Systems, Inc. — 1 clearance
- Medical Analysis Systems, Inc. — 1 clearance
- Eastman Kodak Company — 1 clearance
- Corning Medical & Scientific — 1 clearance
