FDA product code CHS: Coulometric Method, Carbon-Dioxide
CHS is the FDA product code for coulometric method, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 6 510(k) submissions under CHS, from 6 different applicants. The average 510(k) review took 41 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Coulometric Method, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CHS clearance
Top CHS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Analysis Systems, Inc. | 1 | 1993-02-03 |
| Roche Diagnostic Systems, Inc. | 1 | 1991-07-19 |
| Amresco, Inc. | 1 | 1986-03-14 |
| Technicon Instruments Corp. | 1 | 1984-05-02 |
| Corning Medical & Scientific | 1 | 1981-05-27 |
1 more applicants have CHS clearances. See the full list in Caduvo.
Most recent CHS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K926320 | Medical Analysis Systems, Inc. | REFLAB SYSTEM PACK LIQUID CO2 REAGENT | 1993-02-03 | 50 |
| K911838 | Roche Diagnostic Systems, Inc. | ROCHE REAGENT FOR C02 | 1991-07-19 | 85 |
| K860660 | Amresco, Inc. | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | 1986-03-14 | 18 |
| K841080 | Technicon Instruments Corp. | TECHNICON RA-1000 SYS CO2 | 1984-05-02 | 50 |
| K811257 | Corning Medical & Scientific | CORNING 965 CARBON DIOXIDE ANALYZER | 1981-05-27 | 22 |
Recalls for CHS devices
openFDA lists no recalls for product code CHS.
Frequently asked questions
What is FDA product code CHS?
CHS is the FDA product code for coulometric method, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is CHS?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code CHS?
Across 6 cleared submissions the average was 41 days from receipt to decision (median 36).
Which companies have the most CHS clearances?
Medical Analysis Systems, Inc. (1); Roche Diagnostic Systems, Inc. (1); Amresco, Inc. (1); Technicon Instruments Corp. (1); Corning Medical & Scientific (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CHS
- Run a recall and safety report across every CHS manufacturer
- Watch product code CHS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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