FDA product code MJK: Dna Probe, Trichomonas Vaginalis

MJK is the FDA product code for dna probe, trichomonas vaginalis. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MJK. The average 510(k) review took 122 days (median 122). FDA has posted 6 recalls for MJK devices.

Classification

Compare with all 510(k) review times · Search every MJK clearance

Top MJK applicants

Most recent MJK clearances

Recalls for MJK devices

6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-08-28.

Frequently asked questions

What is FDA product code MJK?

MJK is the FDA product code for dna probe, trichomonas vaginalis. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.

What device class is MJK?

Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code MJK?

Across 1 cleared submissions the average was 122 days from receipt to decision (median 122).

Which companies have the most MJK clearances?

Microprobe Corp. (1).

Have MJK devices been recalled?

Yes: 6 product recalls across 5 recall events; the most recent began 2008-08-28.

Next steps

• Run an FDA pathway report with predicate devices for product code MJK
• Run a recall and safety report across every MJK manufacturer
• Watch product code MJK 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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