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FDA 510(k)

ASTar BC G- Kit

K-Number: K253573 · 2026-04-15

ApplicantQ-Linea AB
Decision Date2026-04-15
Product CodeSAN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASTar BC G- Kit is the device name listed in this FDA 510(k) record. The listed applicant is Q-Linea AB. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K253573. The device is classified under product code SAN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASTar BC G- Kit?

ASTar BC G- Kit is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Q-Linea AB. The 510(k) number is K253573.

When did ASTar BC G- Kit receive FDA 510(k) clearance?

ASTar BC G- Kit received FDA 510(k) clearance on 2026-04-15, under 510(k) number K253573.

Who is the listed applicant for ASTar BC G- Kit?

The FDA 510(k) record lists Q-Linea AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTar BC G- Kit?

The FDA product code for ASTar BC G- Kit is SAN.

Other records listing Q-Linea AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221688ASTar BC G- Kit and ASTar Instrument

Related Devices (Code: SAN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystembioMerieux, Inc.K253316PhAST instrument and PhAST Blood Culture Gram-negative PanelPhast Corp.K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLCK241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLCK230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLCK221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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