Source document or public record
FDA 510(k) K220163 — Her-2, ER, PR IHControls
FDA 510(k) index record K220163. Device: Her-2, ER, PR IHControls. Applicant as listed: Boston Cell Standards, Inc.. Decision date: 2022-08-15.
Source
"device_name": "Her-2, ER, PR IHControls"
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 K220163.
Device name: Her-2, ER, PR IHControls. Applicant as listed: Boston Cell Standards, Inc..
Decision date: 2022-08-15. Decision wording: Substantially Equivalent.
Product code: NJW. Regulation: 21 CFR 864.1860. Medical specialty: Hematology.
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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