FDA 510(k)

VITEK REVEAL GN AST 測試與VITEK REVEAL AST 系統

K 號：K230675 · 2024-06-20

決定日期2024-06-20

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

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is the device name listed in this FDA 510(k) record. The listed applicant is Specific Diagnostics, LLC. It received FDA 510(k) clearance on 2024-06-20 under 510(k) number K230675. 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 VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Specific Diagnostics, LLC. The 510(k) number is K230675.

When did VITEK REVEAL GN AST Assay and VITEK REVEAL AST System receive FDA 510(k) clearance?

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System received FDA 510(k) clearance on 2024-06-20, under 510(k) number K230675.

Who is the listed applicant for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA 510(k) record lists Specific Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System?

The FDA product code for VITEK REVEAL GN AST Assay and VITEK REVEAL AST System is SAN.

相關器械（代碼：SAN）

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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 K251875LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統Affinity Biosensors, LLC K241324LifeScale 革蘭氏細菌檢測套件（LSGN）搭配 LifeScale AST 系統Affinity Biosensors, LLC K221688ASTar BC G- Kit 和 ASTar 器材Q-Linea AB

官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：SAN）

官方來源