Source document or public record
FDA 510(k) K211815 — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
FDA 510(k) index record K211815. Device: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System. Applicant as listed: Affinity Biosensors. Decision date: 2024-04-02.
Source
"device_name": "LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System"
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 K211815.
Device name: LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System. Applicant as listed: Affinity Biosensors.
Decision date: 2024-04-02. Decision wording: Substantially Equivalent.
Product code: SAN. Regulation: 21 CFR 866.1650. Medical specialty: Microbiology.
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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