FDA 510(k)

LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統

K 號：K251875 · 2025-10-27

決定日期2025-10-27

產品代碼SAN

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

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.

常見問題

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.

其他以 Affinity Biosensors, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241324LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統

相關器械（代碼：SAN）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260160VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統bioMerieux, Inc.K253316PhAST儀器及PhAST血液培養革蘭氏陰性細菌試劑板Phast Corp.K253573ASTar BC G- KitQ-Linea AB K241324LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統Affinity Biosensors, LLC K230675VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統Specific Diagnostics, LLC K221688ASTar BC G- Kit 和 ASTar 器材Q-Linea AB

官方來源

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