Cleared Traditional

Atellica IM Folate Assay

K172201 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Apr 2018
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K172201 is an FDA 510(k) clearance for the Atellica IM Folate Assay, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 12, 2018, 265 days after receiving the submission on July 21, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K172201 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2017
Decision Date April 12, 2018
Days to Decision 265 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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