Source document or public record
FDA 510(k) K200986 — OPTI® B-Lac Cassette
FDA 510(k) index record K200986. Device: OPTI® B-Lac Cassette. Applicant as listed: Opti Medical Systems, Inc.. Decision date: 2021-08-02.
Source
"device_name": "OPTI® B-Lac Cassette"
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 K200986.
Device name: OPTI® B-Lac Cassette. Applicant as listed: Opti Medical Systems, Inc..
Decision date: 2021-08-02. Decision wording: Substantially Equivalent.
Product code: CHL. Regulation: 21 CFR 862.1120. Medical specialty: Clinical Chemistry.
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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