FDA 510(k)

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

K-Number: K211815 · 2024-04-02

Decision Date2024-04-02

Product CodeSAN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is the device name listed in this FDA 510(k) record. The listed applicant is Affinity Biosensors. It received FDA 510(k) clearance on 2024-04-02 under 510(k) number K211815. 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 LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Affinity Biosensors. The 510(k) number is K211815.

When did LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System receive FDA 510(k) clearance?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System received FDA 510(k) clearance on 2024-04-02, under 510(k) number K211815.

Who is the listed applicant for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

The FDA 510(k) record lists Affinity Biosensors as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

The FDA product code for LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is SAN.

Other records listing Affinity Biosensors 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.

K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system

Related Devices (Code: SAN)

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 AB K251875LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemAffinity Biosensors, LLC K230675VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemSpecific Diagnostics, 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.