BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D— 510(k) K141114

Name: FDA 510(k) clearance K141114
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Substantially Equivalent

Bio-Rad Laboratories

FDA 510(k) clearance K141114 for BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D, Substantially Equivalent on 2015-01-09. Applicant: Bio-Rad Laboratories. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories
Product code: Code MRG
Device class: Class 2
Regulation: 21 CFR 862.1825
Advisory panel: Clinical Chemistry
Date received: 2014-04-30
Decision date: 2015-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Benicia, CA, US

Download summary PDF View on FDA.gov ↗

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