FDA product code MJD: Culture Media, Antimycobacteria, Susceptibility Test
MJD is the FDA product code for culture media, antimycobacteria, susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under MJD, from 2 different applicants. The average 510(k) review took 80 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Culture Media, Antimycobacteria, 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 MJD clearance
Top MJD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Remel Co. | 2 | 1992-06-09 |
| Gibco Laboratories Life Technologies, Inc. | 1 | 1983-03-08 |
Most recent MJD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K920143 | Remel Co. | TB SUSCEPTIBILITY QUADS I AND II | 1992-06-09 | 148 |
| K840981 | Remel Co. | NIACIN REAGENT STRIP | 1984-03-23 | 17 |
| K823859 | Gibco Laboratories Life Technologies, Inc. | MIDDLEBROOK 7H10 AGAR BASE-LOWPH | 1983-03-08 | 76 |
Recalls for MJD devices
openFDA lists no recalls for product code MJD.
Frequently asked questions
What is FDA product code MJD?
MJD is the FDA product code for culture media, antimycobacteria, susceptibility test. It is a Class II device, regulated under 21 CFR 866.1700 and reviewed by the Microbiology panel.
What device class is MJD?
Class II, regulation 21 CFR 866.1700. Typical premarket route: 510(k).
How long does a 510(k) take for product code MJD?
Across 3 cleared submissions the average was 80 days from receipt to decision (median 76).
Which companies have the most MJD clearances?
Remel Co. (2); Gibco Laboratories Life Technologies, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJD
- Run a recall and safety report across every MJD manufacturer
- Watch product code MJD 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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