FDA product code MQJ: Micromanipulators And Microinjectors, Assisted Reproduction

MQJ is the FDA product code for micromanipulators and microinjectors, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6150 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 23 510(k) submissions under MQJ, from 4 different applicants. The average 510(k) review took 43 days (median 33). FDA has posted 1 recall for MQJ devices.

Classification

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

Top MQJ applicants

Most recent MQJ clearances

Recalls for MQJ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-11.

Frequently asked questions

What is FDA product code MQJ?

MQJ is the FDA product code for micromanipulators and microinjectors, assisted reproduction. It is a Class II device, regulated under 21 CFR 884.6150 and reviewed by the Obstetrics and Gynecology panel.

What device class is MQJ?

Class II, regulation 21 CFR 884.6150. Typical premarket route: 510(k) exempt.

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

Across 23 cleared submissions the average was 43 days from receipt to decision (median 33).

Which companies have the most MQJ clearances?

Narishige Co., Ltd. (20); Eppendorf AG (1); Research Instruments , Ltd. (1); <Genx> Intl., Inc. (1).

Have MQJ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2016-03-11.

Next steps

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