FDA 510(k)

SEFRIA甲基安非他命口腔液酶免疫測試

K 號：K203647 · 2021-12-22

決定日期2021-12-22

產品代碼LAF

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決定相當於

器材摘要

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K203647. 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 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Immunalysis Corporation. The 510(k) number is K203647.

When did SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay receive FDA 510(k) clearance?

SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay received FDA 510(k) clearance on 2021-12-22, under 510(k) number K203647.

Who is the listed applicant for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

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 SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay?

The FDA product code for SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay is LAF.

其他以 Immunalysis Corporation 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。

K252520SEFRIA™ Hydrocodone 口服濃縮液 K232898Quantisal™ 口腔液收集器 K223781Quantisal™ II 口腔液收集器 K203564SEFRIA 口服氧鴉片濾液酶免疫分析 K203489SEFRIA PCP 口腔濾液酶免疫分析 K200801Quantisal 口腔液收集器

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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。

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.K153693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Immunalysis Corporation

官方來源

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