CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit— 510(k) K200370

Clearance details

Applicant

Centers for Disease Control and Prevention

Product code

Code OZE

Device class

Class 2

Regulation

21 CFR 866.3980

Advisory panel

Microbiology

Date received

2020-02-14

Decision date

2020-03-10

Decision

Substantially Equivalent

Clearance type

Special

Location

Atlanta, GA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200370.