FDA 510(k) clearance · back to tracker

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

Centers for Disease Control and Prevention cleared K241110 on 2024-05-21, decision: substantially equivalent

K-number

K241110

Sponsor

Centers for Disease Control and Prevention

Device

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)

Class

Class II

Decision

Substantially Equivalent

Decision date

2024-05-21

Product code

OZE

Advisory committee

Microbiology

Medical specialty

Microbiology

Regulation number

866.3980

Official FDA record

Open K241110on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.