Cleared Special

LIAISON? CMV IgG and LIAISON? CMV IgG Serum Control Set

K162969 · DiaSorin, Inc. · Microbiology
Jan 2017
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K162969 is an FDA 510(k) clearance for the LIAISON? CMV IgG and LIAISON? CMV IgG Serum Control Set, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on January 6, 2017, 74 days after receiving the submission on October 24, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K162969 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2016
Decision Date January 06, 2017
Days to Decision 74 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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