CIE
7 FDA 510(k) clearances · Product code
45 daysmedian time to decision
130 days90th percentile
7clearances measured
FDA profile
- Official device name
- Volumetric/Manometric, 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 |
|---|---|---|
| P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (K904761) | Instrumentation Laboratory CO | 1990-11-20 |
| MICRO CO2 APPARATUS (K880967) | Hf Scientific, Inc. | 1988-04-28 |
| CO2 REAGENT SET (K864313) | Hf Scientific, Inc. | 1987-03-13 |
| TOTAL CO2 REAGENT SET (K832071) | American Research Products Co. | 1983-08-11 |
| AIRMED SMOKE EVACUATION & FILTER (K820091) | James L. Geraci & Associates, Inc. | 1982-02-24 |
| SERALYZER REFLECTANCE PHOTOMETER/CALIB. (K800524) | Miles Laboratories, Inc. | 1980-04-02 |
| CARBON DIOXIDE ANALYZER (K771610) | Corning Medical & Scientific | 1977-10-07 |
Track CIE automatically
Every clearance here is in the API, with alerts when new ones post.