FDA 510(k)

Sydney IVF Sperm Cryopreservation Buffer

N.º K: K160814 · 2016-04-22

SolicitanteWilliam A. Cook Australia Pty. , Ltd.

Fecha de decisión2016-04-22

Código de productoMQL

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a William A. Cook Australia Pty. , Ltd. como solicitante

K173431Towako Transmyometrial Embryo Transfer Set K171611Double Lumen Ovum Aspiration Needles K160753COOK Vacuum Pump K170257Sydney IVF Culture Oil K153478Sydney IVF Gamete Buffer K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: MQL)

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato Corporation K252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.