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 a medical device manufactured by Affinity Biosensors. It received FDA 510(k) clearance on 2024-04-02 under approval 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. It is manufactured by Affinity Biosensors. The 510(k) number is K211815.

When was LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System approved by the FDA?

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

What company makes LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System?

LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System is manufactured by Affinity Biosensors.

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.

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Related PubMed Literature

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Related Devices (Code: SAN)

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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.