Coulometric Method, Carbon-Dioxide
FDA product code CHS · Class II (moderate risk) · 21 CFR 862.1160 · Clinical Chemistry
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K926320 | Reflab System Pack Liquid CO2 ReagentCHS · Traditional | Medical Analysis Systems, Inc. | 02/03/1993SE |
| K911838 | Roche Reagent for C02CHS · Traditional | Roche Diagnostic Systems, Inc. | 07/19/1991SE |
| K860660 | Amresco Flow Pac Carbon Dioxide (CO2) ReagentsCHS · Traditional | Amresco, Inc. | 03/14/1986SE |
| K841080 | Technicon RA-1000 Sys CO2CHS · Traditional | Technicon Instruments Corp. | 05/02/1984SE |
| K811257 | Corning 965 Carbon Dioxide AnalyzerCHS · Traditional | Corning Medical & Scientific | 05/27/1981SE |
| K802376 | Kodak Ekta-Chem Clinical Chem. SlidesCHS · Traditional | Eastman Kodak Company | 10/23/1980SE |