Microtools, Assisted Reproduction (Pipettes)

How Is MQH Classified?

Microtools, Assisted Reproduction (Pipettes) is FDA product code MQH, Class 2, 21 CFR 884.6130.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 105 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 4 recalls under this product code since 2007. None was by a company in China. The root cause the FDA records most often is Employee error (3).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.