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FDA 510(k)

ASTar BC G- Kit and ASTar Instrument

K-Number: K221688 · 2024-04-26

ApplicantQ-Linea AB
Decision Date2024-04-26
Product CodeSAN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASTar BC G- Kit and ASTar Instrument 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 2024-04-26 under 510(k) 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. The listed applicant is Q-Linea AB. The 510(k) number is K221688.

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

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

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

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 and ASTar Instrument?

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

K253573ASTar BC G- Kit

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.K253573ASTar BC G- KitQ-Linea ABK251875LifeScale 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, LLC

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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