Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators— 510(k) K153361

Name: FDA 510(k) clearance K153361
Creator: U.S. Food and Drug Administration
Published: 2016-04-15

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K153361 for Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators, Substantially Equivalent on 2016-04-15. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2015-11-20
Decision date: 2016-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, 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.