Source document or public record
FDA 510(k) K222439 — Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)
FDA 510(k) index record K222439. Device: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2023-08-08.
Source
"device_name": "Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K222439.
Device name: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc). Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2023-08-08. Decision wording: Substantially Equivalent.
Product code: LEH. Regulation: 21 CFR 862.3950. Medical specialty: Clinical Toxicology.
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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