XPERT HEMOSIL FACTOR II & FACTOR V ASSAY— 510(k) K082118

Name: FDA 510(k) clearance K082118
Creator: U.S. Food and Drug Administration
Published: 2009-09-18

Substantially Equivalent

Cepheid

FDA 510(k) clearance K082118 for XPERT HEMOSIL FACTOR II & FACTOR V ASSAY, Substantially Equivalent on 2009-09-18. Applicant: Cepheid. Device class: 2.

Clearance details

Applicant: Cepheid
Product code: Code NPQ
Device class: Class 2
Regulation: 21 CFR 864.7280
Advisory panel: Hematology
Date received: 2008-07-28
Decision date: 2009-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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