KMS
5 FDA 510(k) clearances · Product code
34 daysmedian time to decision
67 days90th percentile
5clearances measured
FDA profile
- Official device name
- Phenolphthalein Colorimetry, 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 |
|---|---|---|
| CARBON DIOXIDE (K872886) | Catachem, Inc. | 1987-08-13 |
| AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS (K870025) | American Research Products Co. | 1987-03-13 |
| CO2 COLOR REAGENT & CO2 SAMPLE DILUENT (K802162) | Panmed, Inc. | 1980-10-10 |
| REAGENTS FOR DETERM. CO2 IN HUMAN SERUM (K800681) | Diagnostic Solutions, Inc. | 1980-05-30 |
| CARBON DIOXIDE REAGENTS (K780506) | Gamma Enterprises, Inc. | 1978-05-03 |
Track KMS automatically
Every clearance here is in the API, with alerts when new ones post.