FDA 510(k)

超生物芬太尼尿液檢測套件，超生物免疫荧光分析儀 EASY-11

K 號：K220046 · 2022-12-13

申請人Shenzhen Superbio Technology Co., Ltd.

決定日期2022-12-13

產品代碼DJG

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決定相當於

器材摘要

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Superbio Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-12-13 under 510(k) number K220046. 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 Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is a medical device that received FDA 510(k) clearance on 2022-12-13. The listed applicant is Shenzhen Superbio Technology Co., Ltd.. The 510(k) number is K220046.

When did Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 receive FDA 510(k) clearance?

Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 received FDA 510(k) clearance on 2022-12-13, under 510(k) number K220046.

Who is the listed applicant for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

The FDA 510(k) record lists Shenzhen Superbio Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11?

The FDA product code for Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 is DJG.

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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