FDA 510(k)

LIAISON 抗HAV試劑

K 號：K193532 · 2020-03-02

決定日期2020-03-02

產品代碼LOL

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 Anti-HAV Assay is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2020-03-02 under 510(k) number K193532. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LIAISON Anti-HAV Assay?

LIAISON Anti-HAV Assay is a medical device that received FDA 510(k) clearance on 2020-03-02. The listed applicant is DiaSorin, Inc.. The 510(k) number is K193532.

When did LIAISON Anti-HAV Assay receive FDA 510(k) clearance?

LIAISON Anti-HAV Assay received FDA 510(k) clearance on 2020-03-02, under 510(k) number K193532.

Who is the listed applicant for LIAISON Anti-HAV Assay?

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 Anti-HAV Assay?

The FDA product code for LIAISON Anti-HAV Assay is LOL.

其他以 DiaSorin, Inc. 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。

K260770LIAISON Murex HBsAg Qual；LIAISON XL；LIAISON 稀釋X K231214聯繫VZV IgG HT，聯繫控制VZV IgG HT K223403LIAISON 防HAV；LIAISON XS K213858LIAISON 肠蛋白酶，LIAISON Q.S.E.T. 裝置＋K213936LIAISON MeMed BV, LIAISON MeMed BV 控制組 K193650LIAISON 鐵蛋白

查看所有 25 項裝置 →

相關器械（代碼：LOL）

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。

K260048Elecsys 抗-HAV IgMRoche Diagnostics K251995Access anti-HAV IgMBeckman Coulter, Inc.K243846Access anti-HAVBeckman Coulter, Inc.K222850HAVAb IgG IIAbbott Laboratories K223403LIAISON 防HAV；LIAISON XSDiaSorin, Inc.K210272LIAISON 防HAVDiaSorin, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。