FDA 510(k)

免疫分析甲基安非他命尿液酶免疫分析，免疫分析多藥校准器

K 號：K153693 · 2016-03-18

決定日期2016-03-18

產品代碼LAF

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決定相當於

器材摘要

Immunalysis Methamphetamine 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 2016-03-18 under 510(k) number K153693. The device is classified under product code LAF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Immunalysis Corporation. The 510(k) number is K153693.

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

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators received FDA 510(k) clearance on 2016-03-18, under 510(k) number K153693.

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

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

其他以 Immunalysis Corporation 為申請人之記錄

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相關器械（代碼：LAF）

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。

K203647SEFRIA甲基安非他命口腔液酶免疫測試Immunalysis Corporation K210212Psychemedics 髮絲中安非他命均質酶免疫分析檢測Psychemedics Corporation K201442林致國際有限公司（LZI）Pictus分析儀甲基安非他命酶免疫測試Diatron Group K170222快速毒杯IIAmerican Bio Medica Corp.

官方來源

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