FDA product code MJY: Kit, Serological, Negative Control

MJY is the FDA product code for kit, serological, negative control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MJY. The average 510(k) review took 42 days (median 42).

Classification

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

Top MJY applicants

Most recent MJY clearances

Recalls for MJY devices

openFDA lists no recalls for product code MJY.

Frequently asked questions

What is FDA product code MJY?

MJY is the FDA product code for kit, serological, negative control. It is a Class I device, regulated under 21 CFR 862.1660 and reviewed by the Microbiology panel.

What device class is MJY?

Class I, regulation 21 CFR 862.1660. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 42 days from receipt to decision (median 42).

Which companies have the most MJY clearances?

Pyramid Biological Corp. (1).

Next steps

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