FDA product code FJD: Detector, Leak, Blood
FJD is the FDA product code for detector, leak, blood. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FJD, from 3 different applicants. The average 510(k) review took 110 days (median 101).
Classification
| Field | Value |
|---|---|
| Device name | Detector, Leak, Blood |
| Device class | Class II |
| Regulation | 21 CFR 876.5820 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every FJD clearance
Top FJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Serim Research Corp. | 2 | 2001-11-30 |
| Reprocessing Products Corp | 1 | 2013-03-20 |
| Hach Company | 1 | 2004-12-07 |
Most recent FJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123805 | Reprocessing Products Corp | E-Z CHEK BLOOD LEAK TEST STRIPS | 2013-03-20 | 99 |
| K042322 | Hach Company | STERICHEK BLOOD LEAK REAGENT STRIPS | 2004-12-07 | 103 |
| K012115 | Serim Research Corp. | SERIM BLOOD LEAK TEST STRIP-2 | 2001-11-30 | 147 |
| K990206 | Serim Research Corp. | SERIM BLOOD LEAK TEST STRIP | 1999-04-21 | 90 |
Recalls for FJD devices
openFDA lists no recalls for product code FJD.
Frequently asked questions
What is FDA product code FJD?
FJD is the FDA product code for detector, leak, blood. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJD?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJD?
Across 4 cleared submissions the average was 110 days from receipt to decision (median 101).
Which companies have the most FJD clearances?
Serim Research Corp. (2); Reprocessing Products Corp (1); Hach Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJD
- Run a recall and safety report across every FJD manufacturer
- Watch product code FJD 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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