FDA product code KEJ: Stages, Microscope
KEJ is the FDA product code for stages, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under KEJ. The average 510(k) review took 12 days (median 12).
Classification
| Field | Value |
|---|---|
| Device name | Stages, Microscope |
| Device class | Class I |
| Regulation | 21 CFR 864.3600 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every KEJ clearance
Top KEJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cryodyne Technologies, Inc. | 1 | 1988-04-18 |
Most recent KEJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881467 | Cryodyne Technologies, Inc. | MICROSCOPE STAGE HEATER | 1988-04-18 | 12 |
Recalls for KEJ devices
openFDA lists no recalls for product code KEJ.
Frequently asked questions
What is FDA product code KEJ?
KEJ is the FDA product code for stages, microscope. It is a Class I device, regulated under 21 CFR 864.3600 and reviewed by the Pathology panel.
What device class is KEJ?
Class I, regulation 21 CFR 864.3600. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KEJ?
Across 1 cleared submissions the average was 12 days from receipt to decision (median 12).
Which companies have the most KEJ clearances?
Cryodyne Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KEJ
- Run a recall and safety report across every KEJ manufacturer
- Watch product code KEJ 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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