FDA product code MIY: Enzyme Linked Immunosorbent Assay, Coccidioides Immitis

MIY is the FDA product code for enzyme linked immunosorbent assay, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under MIY. The average 510(k) review took 214 days (median 214).

Classification

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

Top MIY applicants

Most recent MIY clearances

Recalls for MIY devices

openFDA lists no recalls for product code MIY.

Frequently asked questions

What is FDA product code MIY?

MIY is the FDA product code for enzyme linked immunosorbent assay, coccidioides immitis. It is a Class II device, regulated under 21 CFR 866.3135 and reviewed by the Microbiology panel.

What device class is MIY?

Class II, regulation 21 CFR 866.3135. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 214 days from receipt to decision (median 214).

Which companies have the most MIY clearances?

Meridian Diagnostics, Inc. (1).

Next steps

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