Source document or public record
FDA 510(k) K200754 — Hemosure Accu-Reader A100
FDA 510(k) index record K200754. Device: Hemosure Accu-Reader A100. Applicant as listed: W.H.P.M., Inc.. Decision date: 2022-06-02.
Source
"device_name": "Hemosure Accu-Reader A100"
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 K200754.
Device name: Hemosure Accu-Reader A100. Applicant as listed: W.H.P.M., Inc..
Decision date: 2022-06-02. Decision wording: Substantially Equivalent.
Product code: OOX. Regulation: 21 CFR 864.6550. 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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