FDA 510(k)

MAGLUMI 2000 TSH、MAGLUMI 2000 免疫測定分析器

K番号: K162698 · 2017-07-14

申請者Shenzhen New Industries Biomedical Engineering Co., Ltd.

決定日2017-07-14

製品コードJLW

諮問委員会CH 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてShenzhen New Industries Biomedical Engineering Co., Ltd.を記載するその他の記録

K232587MAGLUMI 25-OH ビタミンD、MAGLUMI X3 フルオート化学光免疫測定分析器 K192547MAGLUMI 2000 HCG/β-HCG K191499MAGLUMI 2000 25-OH ビタミンD K182423MAGLUMI 2000 FT4

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