Source document or public record
FDA 510(k) K221688 — ASTar BC G- Kit and ASTar Instrument
FDA 510(k) index record K221688. Device: ASTar BC G- Kit and ASTar Instrument. Applicant as listed: Q-Linea AB. Decision date: 2024-04-26.
Source
"device_name": "ASTar BC G- Kit and ASTar Instrument"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K221688.
Device name: ASTar BC G- Kit and ASTar Instrument. Applicant as listed: Q-Linea AB.
Decision date: 2024-04-26. 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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