FDA 510(k)

Psychemedics 髮絲中芬太尼微板化學免疫測定法

K 號：K182103 · 2019-04-18

決定日期2019-04-18

產品代碼DJG

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決定相當於

器材摘要

Psychemedics Microplate EIA for Fentanyl 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 2019-04-18 under 510(k) number K182103. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Psychemedics Microplate EIA for Fentanyl in Hair?

Psychemedics Microplate EIA for Fentanyl in Hair is a medical device that received FDA 510(k) clearance on 2019-04-18. The listed applicant is Psychemedics Corporation. The 510(k) number is K182103.

When did Psychemedics Microplate EIA for Fentanyl in Hair receive FDA 510(k) clearance?

Psychemedics Microplate EIA for Fentanyl in Hair received FDA 510(k) clearance on 2019-04-18, under 510(k) number K182103.

Who is the listed applicant for Psychemedics Microplate EIA for Fentanyl 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 Microplate EIA for Fentanyl in Hair?

The FDA product code for Psychemedics Microplate EIA for Fentanyl in Hair is DJG.

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 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 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：DJG）

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。

K252684Labcorp 藥物尿檢視測試Medtox Diagnostics, Inc.K250741證據 MultiSTAT 死亡尿多聯合Randox Laboratories Limited K253082LZI Buprenorphine II 酶免疫分析Lin-Zhi International, Inc.K252520SEFRIA™ Hydrocodone 口服濃縮液Immunalysis Corporation K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)測試套件 - 定性；Healgen® 免疫荧光分析儀（OG-H180）Healgen Scientific,, LLC K251634LZI Fentanyl III 酶免疫分析儀Lin-Zhi International, Inc.

官方來源

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