Cleared Traditional

25-OH VITAMIN D ELISA

K123660 · Euroimmun US · Chemistry
Jul 2013
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K123660 is an FDA 510(k) clearance for the 25-OH VITAMIN D ELISA, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on July 17, 2013, 231 days after receiving the submission on November 28, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K123660 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2012
Decision Date July 17, 2013
Days to Decision 231 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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