FDA 510(k)

Psychemedics 髮絲中安非他命均質酶免疫分析檢測

K 號：K210212 · 2021-12-15

決定日期2021-12-15

產品代碼LAF

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

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is the device name listed in this FDA 510(k) record. The listed applicant is Psychemedics Corporation. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K210212. 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 Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Psychemedics Corporation. The 510(k) number is K210212.

When did Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair receive FDA 510(k) clearance?

Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair received FDA 510(k) clearance on 2021-12-15, under 510(k) number K210212.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

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

What is the FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair is LAF.

其他以 Psychemedics 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。

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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 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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