FDA product code DJB: Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
DJB is the FDA product code for radioimmunoassay, gentamicin (125-i), second antibody sep.. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel. FDA has cleared 19 510(k) submissions under DJB, from 13 different applicants. The average 510(k) review took 66 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3450 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DJB clearance
Top DJB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Miles Laboratories, Inc. | 3 | 1983-09-29 |
| Diagnostic Products Corp. | 3 | 1981-07-10 |
| Bio-Rad | 2 | 1979-10-17 |
| New England Nuclear | 2 | 1978-01-05 |
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1983-05-25 |
8 more applicants have DJB clearances. See the full list in Caduvo.
Most recent DJB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K832792 | Miles Laboratories, Inc. | AMES TDA SISOMICIN TEST-CONTROL SERUM | 1983-09-29 | 44 |
| K831210 | E.I. Dupont DE Nemours & Co., Inc. | GENTAMICIN TEST PACK-ACA | 1983-05-25 | 41 |
| K821669 | Miles Laboratories, Inc. | AMES TDA GENTAMICIN TEST | 1982-12-15 | 191 |
| K812394 | Microanalytic Research, Inc. | MRI GENTAMICIN RIA KIT | 1981-09-08 | 19 |
| K811844 | Diagnostic Products Corp. | COAT-A-COUNT GENTAMICIN RIA KIT | 1981-07-10 | 9 |
Recalls for DJB devices
openFDA lists no recalls for product code DJB.
Frequently asked questions
What is FDA product code DJB?
DJB is the FDA product code for radioimmunoassay, gentamicin (125-i), second antibody sep.. It is a Class II device, regulated under 21 CFR 862.3450 and reviewed by the Clinical Toxicology panel.
What device class is DJB?
Class II, regulation 21 CFR 862.3450. Typical premarket route: 510(k).
How long does a 510(k) take for product code DJB?
Across 19 cleared submissions the average was 66 days from receipt to decision (median 43).
Which companies have the most DJB clearances?
Miles Laboratories, Inc. (3); Diagnostic Products Corp. (3); Bio-Rad (2); New England Nuclear (2); E.I. Dupont DE Nemours & Co., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DJB
- Run a recall and safety report across every DJB manufacturer
- Watch product code DJB 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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