Source document or public record
FDA 510(k) K191147 — OC-Auto SENSOR io iFOB Test
FDA 510(k) index record K191147. Device: OC-Auto SENSOR io iFOB Test. Applicant as listed: Eiken Chemical Co., Ltd.. Decision date: 2020-01-02.
Source
"device_name": "OC-Auto SENSOR io iFOB Test"
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 K191147.
Device name: OC-Auto SENSOR io iFOB Test. Applicant as listed: Eiken Chemical Co., Ltd..
Decision date: 2020-01-02. 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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