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FDA 510(k)

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control

K 號：K153596 · 2016-08-09

申請人Ark Diagnostics, Inc.
決定日期2016-08-09
產品代碼POX
諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯： 本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。
決定相當於

器材摘要

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is the device name listed in this FDA 510(k) record. The listed applicant is Ark Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-08-09 under 510(k) number K153596. The device is classified under product code POX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is a medical device that received FDA 510(k) clearance on 2016-08-09. The listed applicant is Ark Diagnostics, Inc.. The 510(k) number is K153596.

When did ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control receive FDA 510(k) clearance?

ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control received FDA 510(k) clearance on 2016-08-09, under 510(k) number K153596.

Who is the listed applicant for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

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

What is the FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control?

The FDA product code for ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK Oxcarbazepine Metabolite Control is POX.

相關臨床試驗

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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。

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