Architect CMV IgG— 510(k) K220949

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K220949 for Architect CMV IgG, Substantially Equivalent on 2022-10-27. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 2022-04-01
Decision date: 2022-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

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