FDA product code MJE: Culture Media, Antifungal, Susceptibility Test
MJE is the FDA product code for culture media, antifungal, susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MJE. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antifungal, Susceptibility Test |
| Device class | Class II |
| Regulation | 21 CFR 866.1700 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MJE clearance
Top MJE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel, Inc. | 1 | 2007-11-26 |
Most recent MJE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K072827 | Remel, Inc. | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE | 2007-11-26 | 54 |
Recalls for MJE devices
openFDA lists no recalls for product code MJE.
Frequently asked questions
What is FDA product code MJE?
MJE is the FDA product code for culture media, antifungal, susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel.
What device class is MJE?
Class II, regulation 21 CFR 866.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJE?
Across 1 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most MJE clearances?
Remel, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJE
- Run a recall and safety report across every MJE manufacturer
- Watch product code MJE 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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