FDA 510(k)

迪亞茲美DZ-Lite iFlash全總beta-hCG測試，迪亞茲美DZ-Lite iFlash 1800化學發光免疫分析儀

K 號：K212221 · 2021-12-13

決定日期2021-12-13

產品代碼DHA

諮詢委員會CH

決定相當於

器材摘要

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2021-12-13 under 510(k) number K212221. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer?

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2021-12-13. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K212221.

When did Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer receive FDA 510(k) clearance?

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer received FDA 510(k) clearance on 2021-12-13, under 510(k) number K212221.

Who is the listed applicant for Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer?

The FDA 510(k) record lists Diazyme Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer?

The FDA product code for Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer is DHA.

其他以 Diazyme Laboratories, Inc. 為申請人之記錄

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K253069脂質蛋白(a)濃度測試 K252336迪亞茲美免疫球蛋白A測試；迪亞茲美免疫球蛋白G測試；迪亞茲美免疫球蛋白M測試 K253358迪亞茲美人類卡帕（k）自由輕鍵結測試；迪亞茲美人類羅馬諾（¿）自由輕鍵結測試 K243462迪亞茲美色譜法鈉鹽測試 K211648迪亞茲美人類卡帕自由輕鏈測試，迪亞茲美人類羅馬拿自由輕鏈測試 K220001迪亞茲美人類卡帕自由輕鏈測試，迪亞茲美人類羅馬拿自由輕鏈測試

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相關器械（代碼：DHA）

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。

K233581VITROS 免疫診斷產品全 β-hCG II 製劑包Ortho Clinical Diagnostics K223690iFlash-HCG；化學發光免疫分析儀（型號：iFlash 3000-C）Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i 全量 β-hCG 試劑套件，GLP系統追蹤Abbott Laboratories K230790Alinity i 全量 β-hCG 試劑套件，Alinity c 葡萄糖試劑套件，Alinity c ICT 樣本稀釋劑，Alinity ci-seriesAbbott Laboratories K221990Access 全總βhCG (第5個IS)Beckman Coulter, Inc.K203227Elecsys HCG STATRoche Diagnostics

官方來源

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