Cleared Traditional

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

K141114 · Bio-Rad Laboratories · Chemistry
Jan 2015
Decision
254d
Days
Class 2
Risk

About This 510(k) Submission

K141114 is an FDA 510(k) clearance for the 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, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on January 9, 2015, 254 days after receiving the submission on April 30, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K141114 FDA.gov
FDA Decision Cleared SESE
Date Received April 30, 2014
Decision Date January 09, 2015
Days to Decision 254 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MRG — System, Test, Vitamin D
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1825

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