FDA 510(k)

Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

K-번호: K152717 · 2016-05-06

신청자William A. Cook Australia Pty. , Ltd.

결정일2016-05-06

제품 코드MQL

자문 위원회의료장비 규제 텍스트 번역 [기업명]의 [제품명]은 미국 식품의약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL]

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

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