DII
5 FDA 510(k) clearances · Product code
35 daysmedian time to decision
58 days90th percentile
5clearances measured
FDA profile
- Official device name
- Columns, Glc
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 1992: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K874824) | Supelco, Inc. | 1988-01-21 |
| CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K862542) | Supelco, Inc. | 1986-08-04 |
| REACTIFS, IBF ULTROGELS ACA & ULTROGELS A (K844164) | Lkb Instruments, Inc. | 1984-12-10 |
| CAPILLARY GAS CHROMATOGRAPHIC COLUMNS (K841712) | Supelco, Inc. | 1984-05-21 |
| 19091-XXXXX SER. OF GLASS CAPILLARY COL. (K791893) | Hewlett-Packard Co. | 1979-10-30 |
Track DII automatically
Every clearance here is in the API, with alerts when new ones post.