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FDA 510(k)

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

K-Number: K251875 · 2025-10-27

ApplicantAffinity Biosensors, LLC
Decision Date2025-10-27
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, LLC. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K251875. 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 2025-10-27. The listed applicant is Affinity Biosensors, LLC. The 510(k) number is K251875.

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 2025-10-27, under 510(k) number K251875.

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

The FDA 510(k) record lists Affinity Biosensors, LLC 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, LLC 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.

K241324LifeScale Gram Negative Kit (LSGN) with the LifeScale AST systemK211815LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System

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 ABK241324LifeScale 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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