FDA product code MJL: Eia, Blastomyces Dermatitidis
MJL is the FDA product code for eia, blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MJL, from 2 different applicants. The average 510(k) review took 54 days (median 54).
Classification
| Field | Value |
|---|---|
| Device name | Eia, Blastomyces Dermatitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3060 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Top MJL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 1 | 1992-10-05 |
| Aries Medical, Inc. | 1 | 1984-03-02 |
Most recent MJL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K923859 | Meridian Diagnostics, Inc. | PREMIER BLASTOMYCES | 1992-10-05 | 66 |
| K840201 | Aries Medical, Inc. | EPIDURAL CATHETER TRAY | 1984-03-02 | 43 |
Recalls for MJL devices
openFDA lists no recalls for product code MJL.
Frequently asked questions
What is FDA product code MJL?
MJL is the FDA product code for eia, blastomyces dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel.
What device class is MJL?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJL?
Across 2 cleared submissions the average was 54 days from receipt to decision (median 54).
Which companies have the most MJL clearances?
Meridian Diagnostics, Inc. (1); Aries Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJL
- Run a recall and safety report across every MJL manufacturer
- Watch product code MJL 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.