FDA 510(k)

Psychemedics均質酵素免疫分析（HEIA）用於檢測頭髮中的芬太尼

K 號：K212952 · 2022-04-18

決定日期2022-04-18

產品代碼LCM

決定相當於

器材摘要

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine 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 2022-04-18 under 510(k) number K212952. The device is classified under product code LCM. FDA Decision: Substantially Equivalent.

常見問題

What is the Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair?

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is a medical device that received FDA 510(k) clearance on 2022-04-18. The listed applicant is Psychemedics Corporation. The 510(k) number is K212952.

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

Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair received FDA 510(k) clearance on 2022-04-18, under 510(k) number K212952.

Who is the listed applicant for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine 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 (HEIA) for Phencyclidine in Hair?

The FDA product code for Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair is LCM.

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。

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 K201228Psychemedics 齊一化酵素免疫分析，用於檢測頭髮中的可卡因 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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相關器械（代碼：LCM）

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。

K203489SEFRIA PCP 口腔濾液酶免疫分析Immunalysis Corporation K181135免疫分析SEFRIA PCP 口腔液酶免疫分析Immunalysis Corporation K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.

官方來源

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