KMS · Phenolphthalein Colorimetry, Carbon-Dioxide
Clinical Chemistry · 21 CFR 862.1160 · Class 2
Overview
| Product Code | KMS |
|---|---|
| Device Name | Phenolphthalein 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872886 | CARBON DIOXIDE | Catachem, Inc. | Aug 13, 1987 | SESE |
| K870025 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | American Research Products Co. | Mar 13, 1987 | SESE |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Panmed, Inc. | Oct 10, 1980 | SESE |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | Diagnostic Solutions, Inc. | May 30, 1980 | SESE |
| K780506 | CARBON DIOXIDE REAGENTS | Gamma Enterprises, Inc. | May 3, 1978 | SESE |
Top Applicants
- American Research Products Co. — 1 clearance
- Catachem, Inc. — 1 clearance
- Diagnostic Solutions, Inc. — 1 clearance
- Gamma Enterprises, Inc. — 1 clearance
- Panmed, Inc. — 1 clearance
