XPERT MTB/RIF ASSAY— 510(k) DEN130032

Unknown

Cepheid

FDA 510(k) clearance DEN130032 for XPERT MTB/RIF ASSAY, Unknown on 2013-07-25. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code PEU
Device class: Class 2
Regulation: 21 CFR 866.3373
Advisory panel: Microbiology
Date received: 2013-06-11
Decision date: 2013-07-25
Decision: Unknown
Clearance type: Direct
Location: Sunnyvale, CA, US

View on FDA.gov ↗

Recent devices under product code PEU

K143302 — Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-802015-02-12

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Data sourced from openFDA. This site is unofficial and independent of the FDA.