Cleared Traditional

Elecsys CMV IgM

K163569 · Roche Diagnostics · Microbiology
Mar 2017
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K163569 is an FDA 510(k) clearance for the Elecsys CMV IgM, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on March 17, 2017, 88 days after receiving the submission on December 19, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K163569 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2016
Decision Date March 17, 2017
Days to Decision 88 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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