FDA product code FJC: Detector, Blood Level
FJC is the FDA product code for detector, blood level. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under FJC. The average 510(k) review took 49 days (median 49).
Classification
| Field | Value |
|---|---|
| Device name | Detector, Blood Level |
| 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 FJC clearance
Top FJC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Welch Allyn, Inc. | 1 | 1995-07-31 |
Most recent FJC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952691 | Welch Allyn, Inc. | WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT | 1995-07-31 | 49 |
Recalls for FJC devices
openFDA lists no recalls for product code FJC.
Frequently asked questions
What is FDA product code FJC?
FJC is the FDA product code for detector, blood level. It is a Class II device, regulated under 21 CFR 876.5820 and reviewed by the Gastroenterology and Urology panel.
What device class is FJC?
Class II, regulation 21 CFR 876.5820. Typical premarket route: 510(k).
How long does a 510(k) take for product code FJC?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most FJC clearances?
Welch Allyn, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FJC
- Run a recall and safety report across every FJC manufacturer
- Watch product code FJC 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.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times