ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)— 510(k) K151906

Clearance details

Applicant

Luminex Corporation

Product code

Code PGI

Device class

Class 2

Regulation

21 CFR 866.3309

Advisory panel

Microbiology

Date received

2015-07-13

Decision date

2015-10-06

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 K151906.