FDA 510(k)

Sydney IVF Sperm Cryopreservation Buffer

K-번호: K160814 · 2016-04-22

신청자William A. Cook Australia Pty. , Ltd.

결정일2016-04-22

제품 코드MQL

자문 위원회OB

결정Substantially Equivalent

기기 요약

Sydney IVF Sperm Cryopreservation Buffer 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 2016-04-22 under 510(k) number K160814. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Sydney IVF Sperm Cryopreservation Buffer?

Sydney IVF Sperm Cryopreservation Buffer is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is William A. Cook Australia Pty. , Ltd.. The 510(k) number is K160814.

When did Sydney IVF Sperm Cryopreservation Buffer receive FDA 510(k) clearance?

Sydney IVF Sperm Cryopreservation Buffer received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160814.

Who is the listed applicant for Sydney IVF Sperm Cryopreservation Buffer?

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 Sperm Cryopreservation Buffer?

The FDA product code for Sydney IVF Sperm Cryopreservation Buffer is MQL.

William A. Cook Australia Pty. , Ltd.를 신청인으로 등재한 기타 기록

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