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FDA 510(k)

MAGLUMI 2000 TSH, MAGLUMI 2000 適用化分析儀

K 號：K162698 · 2017-07-14

申請人Shenzhen New Industries Biomedical Engineering Co., Ltd.
決定日期2017-07-14
產品代碼JLW
諮詢委員會CH
決定相當於

器材摘要

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2017-07-14 under 510(k) number K162698. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K162698.

When did MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer receive FDA 510(k) clearance?

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer received FDA 510(k) clearance on 2017-07-14, under 510(k) number K162698.

Who is the listed applicant for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

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

What is the FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer?

The FDA product code for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer is JLW.

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其他以 Shenzhen New Industries Biomedical Engineering Co., Ltd. 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。

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相關器械（代碼：JLW）

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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官方來源

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