Coulometric Method, Carbon-Dioxide
The Coulometric Method, Carbon Dioxide test system (product code CHS) is an in-vitro diagnostic device used in clinical chemistry to measure carbon dioxide (CO2) or bicarbonate concentrations in biological specimens using coulometric measurement, supporting the evaluation of acid-base and electrolyte status. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1160 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CHS
- Device Class
- FDA class 2
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K926320 | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | Feb 03, 1993 | Substantially Equivalent | Medical Analysis Systems, Inc. |
| K911838 | ROCHE REAGENT FOR C02 | Jul 19, 1991 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K860660 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Mar 14, 1986 | Substantially Equivalent | Amresco, Inc. |
| K841080 | TECHNICON RA-1000 SYS CO2 | May 02, 1984 | Substantially Equivalent | Technicon Instruments Corp. |
| K811257 | CORNING 965 CARBON DIOXIDE ANALYZER | May 27, 1981 | Substantially Equivalent | Corning Medical & Scientific |
| K802376 | KODAK EKTA-CHEM CLINICAL CHEM. SLIDES | Oct 23, 1980 | Substantially Equivalent | Eastman Kodak Company |