FDA product code DPM: Columns, Liquid Chromatography
DPM is the FDA product code for columns, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel. FDA has cleared 16 510(k) submissions under DPM, from 6 different applicants. The average 510(k) review took 51 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Columns, Liquid Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2260 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DPM clearance
Top DPM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Supelco, Inc. | 10 | 1989-08-21 |
| Waters Chemical Products | 2 | 1989-10-06 |
| Chimera Research & Chemical, Inc. | 1 | 1995-08-24 |
| Millipore Corp. | 1 | 1987-01-09 |
| Hamilton Co. | 1 | 1983-08-16 |
1 more applicants have DPM clearances. See the full list in Caduvo.
Most recent DPM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952501 | Chimera Research & Chemical, Inc. | TOX PERFECT B TUBES AND REAGENTS | 1995-08-24 | 86 |
| K895105 | Waters Chemical Products | HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE | 1989-10-06 | 52 |
| K894141 | Supelco, Inc. | LIQUID CHROMATOGRAPHY COLUMNS | 1989-08-21 | 69 |
| K891673 | Waters Chemical Products | ADVANCED PURIFICATION GLASS COLUMN | 1989-04-26 | 36 |
| K884403 | Supelco, Inc. | LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE | 1988-12-22 | 64 |
Recalls for DPM devices
openFDA lists no recalls for product code DPM.
Frequently asked questions
What is FDA product code DPM?
DPM is the FDA product code for columns, liquid chromatography. It is a Class I device, regulated under 21 CFR 862.2260 and reviewed by the Clinical Toxicology panel.
What device class is DPM?
Class I, regulation 21 CFR 862.2260. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DPM?
Across 16 cleared submissions the average was 51 days from receipt to decision (median 46).
Which companies have the most DPM clearances?
Supelco, Inc. (10); Waters Chemical Products (2); Chimera Research & Chemical, Inc. (1); Millipore Corp. (1); Hamilton Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DPM
- Run a recall and safety report across every DPM manufacturer
- Watch product code DPM 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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