Cleared Traditional

ELECSYS FOLATE III

K141426 · Roche Diagnostics · Chemistry
Oct 2014
Decision
140d
Days
Class 2
Risk

About This 510(k) Submission

K141426 is an FDA 510(k) clearance for the ELECSYS FOLATE III, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 17, 2014, 140 days after receiving the submission on May 30, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K141426 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2014
Decision Date October 17, 2014
Days to Decision 140 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGN — Acid, Folic, Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1295

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