Cleared Traditional

Architect CMV IgG

K220949 · Abbott Laboratories · Microbiology
Oct 2022
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K220949 is an FDA 510(k) clearance for the Architect CMV IgG, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 27, 2022, 209 days after receiving the submission on April 1, 2022. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K220949 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2022
Decision Date October 27, 2022
Days to Decision 209 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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