Panther Fusion Paraflu Assay— 510(k) K172282

Substantially Equivalent

Hologic, Inc.

FDA 510(k) clearance K172282 for Panther Fusion Paraflu Assay, Substantially Equivalent on 2017-10-23. Applicant: Hologic, Inc.. Device class: 2.

Clearance details

Applicant: Hologic, Inc.
Product code: Code OOU
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2017-07-28
Decision date: 2017-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OOU

K153223 — ProParaFlu+ Assay2015-12-09
K141927 — LYRA PARAINFLUENZA VIRUS ASSAY2014-10-09
K132238 — PROPARAFLU+ ASSAY2013-08-26
K091053 — PROPARAFLU+ASSAY2009-11-20

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