Cleared Traditional

IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set

K161831 · Immunodiagnostic Systems , Ltd. · Chemistry
Nov 2016
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K161831 is an FDA 510(k) clearance for the IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set, a System, Test, Vitamin D (Class II — Special Controls, product code MRG), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on November 15, 2016, 133 days after receiving the submission on July 5, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1825.

Submission Details

510(k) Number K161831 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2016
Decision Date November 15, 2016
Days to Decision 133 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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