Volumetric/Manometric, Carbon-Dioxide
FDA product code CIE · Class II (moderate risk) · 21 CFR 862.1160 · Clinical Chemistry
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K904761 | P/N 35310, Il Test Alkaline Phosphatase ReagentCIE · Traditional | Instrumentation Laboratory CO | 11/20/1990SE |
| K880967 | Micro CO2 ApparatusCIE · Traditional | Hf Scientific, Inc. | 04/28/1988SE |
| K864313 | CO2 Reagent SetCIE · Traditional | Hf Scientific, Inc. | 03/13/1987SE |
| K832071 | Total CO2 Reagent SetCIE · Traditional | American Research Products Co. | 08/11/1983SE |
| K820091 | Airmed Smoke Evacuation & FilterCIE · Traditional | James L. Geraci & Associates, Inc. | 02/24/1982SE |
| K800524 | Seralyzer Reflectance Photometer/Calib.CIE · Traditional | Miles Laboratories, Inc. | 04/02/1980SE |
| K771610 | Carbon Dioxide AnalyzerCIE · Traditional | Corning Medical & Scientific | 10/07/1977SE |