FDA 510(k)

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

Número K: K152682 · 2016-05-05

RequerenteWillian A. Cook Australia Pty, Ltd.

Data da decisão2016-05-05

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is the device name listed in this FDA 510(k) record. The listed applicant is Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) number K152682. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is a medical device that received FDA 510(k) clearance on 2016-05-05. The listed applicant is Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K152682.

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

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit received FDA 510(k) clearance on 2016-05-05, under 510(k) number K152682.

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

The FDA 510(k) record lists Willian 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 Cryopreservation Kit, Sydney IVF Thawing Kit?

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

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Fonte oficial

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