Elecsys CMV IgM— 510(k) K163569

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K163569 for Elecsys CMV IgM, Substantially Equivalent on 2017-03-17. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 2016-12-19
Decision date: 2017-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

K220949 — Architect CMV IgG2022-10-27
K220911 — Elecsys CMV IgG2022-10-12
K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06
K142133 — ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM2014-10-24

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K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
K260046 — Elecsys Anti-HBc II2026-04-07
K260048 — Elecsys Anti-HAV IgM2026-04-07

Recalls naming K163569

K-number listed on FDA's recall record

Z-1249-2019 — cobas e 801 immunoassay analyzerClass II·Terminated·Roche Diagnostics Corporation·20190315
Z-2136-2018 — cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.Class II·Terminated·Roche Diagnostics Corporation·20180403

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163569.

Data sourced from openFDA. This site is unofficial and independent of the FDA.