FDA product code DBJ: Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
DBJ is the FDA product code for antiparietal antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5110 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under DBJ, from 2 different applicants. The average 510(k) review took 146 days (median 146).
Classification
| Field | Value |
|---|---|
| Device name | Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5110 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DBJ clearance
Top DBJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Elias U.S.A., Inc. | 1 | 1993-08-03 |
| Medica Corp. | 1 | 1979-07-30 |
Most recent DBJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K930422 | Elias U.S.A., Inc. | SYNELISA PARIETAL CELL ANTIBODIES | 1993-08-03 | 189 |
| K790759 | Medica Corp. | IIF-APCA TEST KIT | 1979-07-30 | 104 |
Recalls for DBJ devices
openFDA lists no recalls for product code DBJ.
Frequently asked questions
What is FDA product code DBJ?
DBJ is the FDA product code for antiparietal antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5110 and reviewed by the Immunology panel.
What device class is DBJ?
Class II, regulation 21 CFR 866.5110. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBJ?
Across 2 cleared submissions the average was 146 days from receipt to decision (median 146).
Which companies have the most DBJ clearances?
Elias U.S.A., Inc. (1); Medica Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DBJ
- Run a recall and safety report across every DBJ manufacturer
- Watch product code DBJ 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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