FDA 510(k)

ASTar BC G- Kit and ASTar Instrument

K-Number: K221688 · 2024-04-26

Decision Date2024-04-26

Product CodeSAN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

ASTar BC G- Kit and ASTar Instrument is a medical device manufactured by Q-Linea AB. It received FDA 510(k) clearance on 2024-04-26 under approval number K221688. 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 and ASTar Instrument?

ASTar BC G- Kit and ASTar Instrument is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by Q-Linea AB. The 510(k) number is K221688.

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

ASTar BC G- Kit and ASTar Instrument received FDA 510(k) clearance on 2024-04-26, under approval number K221688.

What company makes ASTar BC G- Kit and ASTar Instrument?

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

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

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

Other Devices by Q-Linea AB

K253573ASTar BC G- Kit

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 K211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST SystemAffinity Biosensors K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K253573ASTar BC G- KitQ-Linea AB

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.