FDA product code JWK: Antigen, Positive Control, Cryptococcus Neoformans

JWK is the FDA product code for antigen, positive control, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under JWK. The average 510(k) review took 21 days (median 21).

Classification

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

Top JWK applicants

Most recent JWK clearances

Recalls for JWK devices

openFDA lists no recalls for product code JWK.

Frequently asked questions

What is FDA product code JWK?

JWK is the FDA product code for antigen, positive control, cryptococcus neoformans. It is a Class II device, regulated under 21 CFR 866.3165 and reviewed by the Microbiology panel.

What device class is JWK?

Class II, regulation 21 CFR 866.3165. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 21 days from receipt to decision (median 21).

Which companies have the most JWK clearances?

Meridian Diagnostics, Inc. (1).

Next steps

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