Source document or public record
FDA 510(k) K220949 — Architect CMV IgG
FDA 510(k) index record K220949. Device: Architect CMV IgG. Applicant as listed: Abbott Laboratories. Decision date: 2022-10-27.
Source
"device_name": "Architect CMV IgG"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K220949.
Device name: Architect CMV IgG. Applicant as listed: Abbott Laboratories.
Decision date: 2022-10-27. Decision wording: Substantially Equivalent.
Product code: LFZ. Regulation: 21 CFR 866.3175. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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