FDA 510(k)

免疫分析苯二氮平類尿液酶免疫分析儀，免疫分析多藥校准儀

K 號：K151771 · 2016-01-05

決定日期2016-01-05

產品代碼JXM

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 Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2016-01-05 under 510(k) number K151771. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is a medical device that received FDA 510(k) clearance on 2016-01-05. The listed applicant is Immunalysis Corporation. The 510(k) number is K151771.

When did Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators receive FDA 510(k) clearance?

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators received FDA 510(k) clearance on 2016-01-05, under 510(k) number K151771.

Who is the listed applicant for Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

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

What is the FDA product code for Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

The FDA product code for Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is JXM.

其他以 Immunalysis Corporation 為申請人之記錄

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相關器械（代碼：JXM）

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。

K243498Alinity c 苯二氮卓鹽試劑套件Microgenics Corporation K221765網上資料 Benzodiazepines IIRoche Diagnostics K190968CEDIA 苯二氮平試驗Microgenics Corporation K173963DRI 苯二氮平試驗Microgenics Corporation K163590Psychemedics 髮絲中苯二氮䓬類微板酶免疫測試Psychemedics Corporation K163704Healgen 多藥尿液檢測杯；Healgen 多藥尿液檢測濾紙卡Healgen Scientific,, LLC

官方來源

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