FDA 510(k)

EliA抗TG免疫測定、EliA抗TPO免疫測定、EliA甲状腺ポジティブコントロール250、EliA甲状腺ポジティブコントロール2500/5000

K番号: K151799 · 2016-03-25

決定日2016-03-25

製品コードJZO

諮問委員会IM 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。詳細情報や製品の使用方法については、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

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K151799. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Phadia AB. The 510(k) number is K151799.

When did EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 receive FDA 510(k) clearance?

EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 received FDA 510(k) clearance on 2016-03-25, under 510(k) number K151799.

Who is the listed applicant for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

The FDA 510(k) record lists Phadia AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000?

The FDA product code for EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 is JZO.