FDA product code DII: Columns, Glc
DII is the FDA product code for columns, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel. FDA has cleared 5 510(k) submissions under DII, from 3 different applicants. The average 510(k) review took 40 days (median 35).
Classification
| Field | Value |
|---|---|
| Device name | Columns, Glc |
| Device class | Class I |
| Regulation | 21 CFR 862.2250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DII clearance
Top DII applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Supelco, Inc. | 3 | 1988-01-21 |
| Lkb Instruments, Inc. | 1 | 1984-12-10 |
| Hewlett-Packard Co. | 1 | 1979-10-30 |
Most recent DII clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K874824 | Supelco, Inc. | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | 1988-01-21 | 58 |
| K862542 | Supelco, Inc. | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY | 1986-08-04 | 32 |
| K844164 | Lkb Instruments, Inc. | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | 1984-12-10 | 46 |
| K841712 | Supelco, Inc. | CAPILLARY GAS CHROMATOGRAPHIC COLUMNS | 1984-05-21 | 27 |
| K791893 | Hewlett-Packard Co. | 19091-XXXXX SER. OF GLASS CAPILLARY COL. | 1979-10-30 | 35 |
Recalls for DII devices
openFDA lists no recalls for product code DII.
Frequently asked questions
What is FDA product code DII?
DII is the FDA product code for columns, glc. It is a Class I device, regulated under 21 CFR 862.2250 and reviewed by the Clinical Toxicology panel.
What device class is DII?
Class I, regulation 21 CFR 862.2250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DII?
Across 5 cleared submissions the average was 40 days from receipt to decision (median 35).
Which companies have the most DII clearances?
Supelco, Inc. (3); Lkb Instruments, Inc. (1); Hewlett-Packard Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DII
- Run a recall and safety report across every DII manufacturer
- Watch product code DII 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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