FDA product code MJM: Dna Probe, Gardnerella Vaginalis
MJM is the FDA product code for dna probe, gardnerella vaginalis. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under MJM, from 2 different applicants. The average 510(k) review took 172 days (median 172).
Classification
| Field | Value |
|---|---|
| Device name | Dna Probe, Gardnerella Vaginalis |
| Device class | Class I |
| Regulation | 21 CFR 866.2660 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MJM clearance
Top MJM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Litmus Concepts, Inc. | 1 | 1997-06-19 |
| Microprobe Corp. | 1 | 1992-09-25 |
Most recent MJM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964015 | Litmus Concepts, Inc. | INDICARD TEST | 1997-06-19 | 255 |
| K923133 | Microprobe Corp. | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | 1992-09-25 | 88 |
Recalls for MJM devices
openFDA lists no recalls for product code MJM.
Frequently asked questions
What is FDA product code MJM?
MJM is the FDA product code for dna probe, gardnerella vaginalis. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.
What device class is MJM?
Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MJM?
Across 2 cleared submissions the average was 172 days from receipt to decision (median 172).
Which companies have the most MJM clearances?
Litmus Concepts, Inc. (1); Microprobe Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MJM
- Run a recall and safety report across every MJM manufacturer
- Watch product code MJM 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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