FDA 510(k)

ASTar BC G- Kit

K-Number: K253573 · 2026-04-15

Decision Date2026-04-15

Product CodeSAN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ASTar BC G- Kit is a medical device manufactured by Q-Linea AB. It received FDA 510(k) clearance on 2026-04-15 under approval 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. It is manufactured by Q-Linea AB. The 510(k) number is K253573.

When was ASTar BC G- Kit approved by the FDA?

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

What company makes ASTar BC G- Kit?

ASTar BC G- Kit is manufactured by Q-Linea AB.

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

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

Other Devices by Q-Linea AB

K221688ASTar BC G- Kit and ASTar Instrument

Related Devices (Code: SAN)

K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, LLC K221688ASTar BC G- Kit and ASTar InstrumentQ-Linea AB K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC

Official Source

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