Cleared Traditional

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

K122397 · DiaSorin, Inc. · Microbiology
Sep 2012
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K122397 is an FDA 510(k) clearance for the LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on September 6, 2012, 30 days after receiving the submission on August 7, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K122397 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2012
Decision Date September 06, 2012
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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