VANTERA CLINICAL ANALYZER— 510(k) K113830

Substantially Equivalent

Liposcience

FDA 510(k) clearance K113830 for VANTERA CLINICAL ANALYZER, Substantially Equivalent on 2012-08-30. Applicant: Liposcience. Device class: 1.

Clearance details

Applicant: Liposcience
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 2011-12-27
Decision date: 2012-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, 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.