FDA 510(k)

ASTar BC G- Kit

K 號：K253573 · 2026-04-15

決定日期2026-04-15

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

ASTar BC G- Kit is the device name listed in this FDA 510(k) record. The listed applicant is Q-Linea AB. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K253573. 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 ASTar BC G- Kit?

ASTar BC G- Kit is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is Q-Linea AB. The 510(k) number is K253573.

When did ASTar BC G- Kit receive FDA 510(k) clearance?

ASTar BC G- Kit received FDA 510(k) clearance on 2026-04-15, under 510(k) number K253573.

Who is the listed applicant for ASTar BC G- Kit?

The FDA 510(k) record lists Q-Linea AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASTar BC G- Kit?

The FDA product code for ASTar BC G- Kit is SAN.

其他以 Q-Linea AB 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。

K221688ASTar BC G- Kit 和 ASTar 器材

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.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 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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