FDA product code DJY: Ion-Exchange Chromatography
DJY is the FDA product code for ion-exchange chromatography. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel. FDA has cleared 11 510(k) submissions under DJY, from 7 different applicants. The average 510(k) review took 66 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Ion-Exchange Chromatography |
| Device class | Class I |
| Regulation | 21 CFR 862.2230 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DJY clearance
Top DJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 4 | 1985-03-25 |
| Supelco, Inc. | 2 | 1988-12-16 |
| Cardiovascular Devices, Inc. | 1 | 1989-05-23 |
| Lkb Instruments, Inc. | 1 | 1984-04-19 |
| Hamilton Co. | 1 | 1983-08-12 |
2 more applicants have DJY clearances. See the full list in Caduvo.
Most recent DJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890113 | Cardiovascular Devices, Inc. | THE CDI(R) SYSTEM 400 | 1989-05-23 | 132 |
| K883615 | Supelco, Inc. | LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 | 1988-12-16 | 114 |
| K881361 | Supelco, Inc. | SOLID PHASE EXTRACTION TUBES | 1988-08-08 | 174 |
| K850963 | E.I. Dupont DE Nemours & Co., Inc. | DUPONT PREP TYPE SI EXTRACITON CARTRIDGE | 1985-03-25 | 17 |
| K840985 | Lkb Instruments, Inc. | TRISACRYL GF 05 & TRISACRYL GF 2000 | 1984-04-19 | 43 |
Recalls for DJY devices
openFDA lists no recalls for product code DJY.
Frequently asked questions
What is FDA product code DJY?
DJY is the FDA product code for ion-exchange chromatography. It is a Class I device, regulated under 21 CFR 862.2230 and reviewed by the Clinical Toxicology panel.
What device class is DJY?
Class I, regulation 21 CFR 862.2230. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DJY?
Across 11 cleared submissions the average was 66 days from receipt to decision (median 43).
Which companies have the most DJY clearances?
E.I. Dupont DE Nemours & Co., Inc. (4); Supelco, Inc. (2); Cardiovascular Devices, Inc. (1); Lkb Instruments, Inc. (1); Hamilton Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJY
- Run a recall and safety report across every DJY manufacturer
- Watch product code DJY 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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