FDA 510(k)

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

K 號：K252336 · 2026-04-24

決定日期2026-04-24

產品代碼

決定相當於

器材摘要

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay 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 2026-04-24 under 510(k) number K252336. FDA Decision: Substantially Equivalent.

常見問題

What is the Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay?

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K252336.

When did Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay receive FDA 510(k) clearance?

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay received FDA 510(k) clearance on 2026-04-24, under 510(k) number K252336.

Who is the listed applicant for Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay?

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

其他以 Diazyme Laboratories, Inc. 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。

K253069脂質蛋白(a)濃度測試 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 K212221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

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官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

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

官方來源