Cleared Traditional

ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS

K110619 · Biokit, S.A. · Chemistry
Nov 2011
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K110619 is an FDA 510(k) clearance for the ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Biokit, S.A. (Llissa D'Amunt, Barcelona, ES). The FDA issued a Cleared decision on November 23, 2011, 265 days after receiving the submission on March 3, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K110619 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2011
Decision Date November 23, 2011
Days to Decision 265 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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