FDA 510(k)

免疫分析膽堿那非尿液中檢測試劑

K 號：K203527 · 2022-05-09

決定日期2022-05-09

產品代碼DJG

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

決定相當於

器材摘要

Immunalysis Tapentadol Urine HEIA is the device name listed in this FDA 510(k) record. The listed applicant is Lmmunalysis Corporation. It received FDA 510(k) clearance on 2022-05-09 under 510(k) number K203527. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Immunalysis Tapentadol Urine HEIA?

Immunalysis Tapentadol Urine HEIA is a medical device that received FDA 510(k) clearance on 2022-05-09. The listed applicant is Lmmunalysis Corporation. The 510(k) number is K203527.

When did Immunalysis Tapentadol Urine HEIA receive FDA 510(k) clearance?

Immunalysis Tapentadol Urine HEIA received FDA 510(k) clearance on 2022-05-09, under 510(k) number K203527.

Who is the listed applicant for Immunalysis Tapentadol Urine HEIA?

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

What is the FDA product code for Immunalysis Tapentadol Urine HEIA?

The FDA product code for Immunalysis Tapentadol Urine HEIA is DJG.

相關器械（代碼：DJG）

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。

K252684Labcorp 藥物尿檢視測試Medtox Diagnostics, Inc.K250741證據 MultiSTAT 死亡尿多聯合Randox Laboratories Limited K253082LZI Buprenorphine II 酶免疫分析Lin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone 口服濃縮液Immunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）Healgen Scientific,, LLC K251634LZI Fentanyl III 酶免疫分析儀Lin-Zhi International, 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。