Culture Media, Non-Propagating Transport

How Is JSM Classified?

Culture Media, Non-Propagating Transport is FDA product code JSM, Class 1, 21 CFR 866.2390.

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 9 clearances under this code; the FDA took a median of 248 days from receipt to decision on them.

1 was reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 18 recalls under this product code since 2009. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Environmental control (4), Process control (2) and Device Design (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.