Source document or public record
FDA 510(k) K213348 — BOND MMR Antibody Panel
FDA 510(k) index record K213348. Device: BOND MMR Antibody Panel. Applicant as listed: Leica Biosystems Newcastle, Ltd.. Decision date: 2023-02-21.
Source
"device_name": "BOND MMR Antibody Panel"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K213348.
Device name: BOND MMR Antibody Panel. Applicant as listed: Leica Biosystems Newcastle, Ltd..
Decision date: 2023-02-21. Decision wording: Substantially Equivalent.
Product code: PZJ. Regulation: 21 CFR 864.1866. Medical specialty: Immunology.
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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