Cleared Traditional

ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY

K131605 · Roche Diagnostics · Microbiology
Feb 2014
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K131605 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Roche Diagnostics (Indianaoplis, US). The FDA issued a Cleared decision on February 28, 2014, 270 days after receiving the submission on June 3, 2013. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K131605 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date February 28, 2014
Days to Decision 270 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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