FDA 510(k)

シドニーIVF blastocyst冷凍保存キット、シドニーIVF blastocyst解凍キット

K番号: K152717 · 2016-05-06

申請者William A. Cook Australia Pty. , Ltd.

決定日2016-05-06

製品コードMQL

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit is the device name listed in this FDA 510(k) record. The listed applicant is William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152717. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit?

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K152717.

When did Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit receive FDA 510(k) clearance?

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152717.

Who is the listed applicant for Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit?

The FDA 510(k) record lists William A. Cook Australia Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit?

The FDA product code for Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit is MQL.

申請者としてWilliam A. Cook Australia Pty. , Ltd.を記載するその他の記録

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すべての9件のデバイスを表示 →

公式ソース

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