Cleared Traditional

ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control

K181213 · Siemens Healthcare Diagnostics, Inc. · Microbiology
Jul 2018
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K181213 is an FDA 510(k) clearance for the ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 30, 2018, 84 days after receiving the submission on May 7, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K181213 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2018
Decision Date July 30, 2018
Days to Decision 84 days
Submission Type Traditional
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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