FDA 510(k)

LIAISON Murex HBsAg Qual；LIAISON XL；LIAISON 稀釋X

K 號：K260770 · 2026-06-04

決定日期2026-06-04

產品代碼LOM

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

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260770. The device is classified under product code LOM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is DiaSorin, Inc.. The 510(k) number is K260770.

When did LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX receive FDA 510(k) clearance?

LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260770.

Who is the listed applicant for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

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

What is the FDA product code for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX?

The FDA product code for LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX is LOM.

其他以 DiaSorin, Inc. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 DiaSorin, Inc. 為申請人之記錄

官方來源