CHS
6 FDA 510(k) clearances · Product code
50 daysmedian time to decision
85 days90th percentile
6clearances measured
FDA profile
- Official device name
- Coulometric Method, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| REFLAB SYSTEM PACK LIQUID CO2 REAGENT (K926320) | Medical Analysis Systems, Inc. | 1993-02-03 |
| ROCHE REAGENT FOR C02 (K911838) | Roche Diagnostic Systems, Inc. | 1991-07-19 |
| AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K860660) | Amresco, Inc. | 1986-03-14 |
| TECHNICON RA-1000 SYS CO2 (K841080) | Technicon Instruments Corp. | 1984-05-02 |
| CORNING 965 CARBON DIOXIDE ANALYZER (K811257) | Corning Medical & Scientific | 1981-05-27 |
| KODAK EKTA-CHEM CLINICAL CHEM. SLIDES (K802376) | Eastman Kodak Company | 1980-10-23 |
Track CHS automatically
Every clearance here is in the API, with alerts when new ones post.