ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit— 510(k) K163626

Clearance details

Applicant

Luminex Corporation

Product code

Code OZZ

Device class

Class 2

Regulation

21 CFR 866.3980

Advisory panel

Microbiology

Date received

2016-12-22

Decision date

2017-05-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Austin, TX, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163626.