Cleared Traditional

LIAISON? Folate

K192586 · DiaSorin, Inc. · Chemistry
May 2020
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K192586 is an FDA 510(k) clearance for the LIAISON? Folate, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on May 6, 2020, 230 days after receiving the submission on September 19, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K192586 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2019
Decision Date May 06, 2020
Days to Decision 230 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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