CIE · Volumetric/Manometric, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | CIE |
|---|---|
| Device Name | Volumetric/Manometric, 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 (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904761 | P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT | Instrumentation Laboratory CO | Nov 20, 1990 | SESE |
| K880967 | MICRO CO2 APPARATUS | Hf Scientific, Inc. | Apr 28, 1988 | SESE |
| K864313 | CO2 REAGENT SET | Hf Scientific, Inc. | Mar 13, 1987 | SESE |
| K832071 | TOTAL CO2 REAGENT SET | American Research Products Co. | Aug 11, 1983 | SESE |
| K820091 | AIRMED SMOKE EVACUATION & FILTER | James L. Geraci & Associates, Inc. | Feb 24, 1982 | SESE |
| K800524 | SERALYZER REFLECTANCE PHOTOMETER/CALIB. | Miles Laboratories, Inc. | Apr 2, 1980 | SESE |
| K771610 | CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | Oct 7, 1977 | SESE |
Top Applicants
- Hf Scientific, Inc. — 2 clearances
- Miles Laboratories, Inc. — 1 clearance
- James L. Geraci & Associates, Inc. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
- Corning Medical & Scientific — 1 clearance
