FDA product code JSR: Kit, Identification, Dermatophyte

JSR is the FDA product code for kit, identification, dermatophyte. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under JSR. The average 510(k) review took 38 days (median 38).

Classification

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

Top JSR applicants

Most recent JSR clearances

Recalls for JSR devices

openFDA lists no recalls for product code JSR.

Frequently asked questions

What is FDA product code JSR?

JSR is the FDA product code for kit, identification, dermatophyte. It is a Class I device, regulated under 21 CFR 866.2660 and reviewed by the Microbiology panel.

What device class is JSR?

Class I, regulation 21 CFR 866.2660. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 38 days from receipt to decision (median 38).

Which companies have the most JSR clearances?

Isle Media and Sterile Products, Inc. (1).

Next steps

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