FDA 510(k)

Psychemedics 齊一化酵素免疫分析，用於檢測頭髮中的可卡因

K 號：K201228 · 2021-06-25

決定日期2021-06-25

產品代碼JXO

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 Cocaine 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 2021-06-25 under 510(k) number K201228. The device is classified under product code JXO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair?

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Psychemedics Corporation. The 510(k) number is K201228.

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

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair received FDA 510(k) clearance on 2021-06-25, under 510(k) number K201228.

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

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair is JXO.

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。

K212952Psychemedics均質酵素免疫分析（HEIA）用於檢測頭髮中的芬太尼 K210212Psychemedics 髮絲中安非他命均質酶免疫分析檢測 K201326Psychemedics均質酵素免疫分析（HEIA）用於頭髮中的阿片，Psychemedics均質酵素免疫分析（HEIA）用於頭髮中的氧可酮 K192517Psychemedics 髮毛尼古丁微板化學免疫測定法 K182103Psychemedics 髮絲中芬太尼微板化學免疫測定法 K163590Psychemedics 髮絲中苯二氮䓬類微板酶免疫測試

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官方來源

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