Cleared Traditional

ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM

K142133 · Roche Diagnostics · Microbiology
Oct 2014
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K142133 is an FDA 510(k) clearance for the ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 24, 2014, 81 days after receiving the submission on August 4, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K142133 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2014
Decision Date October 24, 2014
Days to Decision 81 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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