Cleared Traditional

Elecsys Folate III

K233060 · Roche Diagnostics · Chemistry
Jun 2024
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K233060 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 June 17, 2024, 266 days after receiving the submission on September 25, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K233060 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2023
Decision Date June 17, 2024
Days to Decision 266 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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