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FDA 510(k)

Sydney IVF Sperm Cryopreservation Buffer

K-Number: K160814 · 2016-04-22

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2016-04-22
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sydney IVF Sperm Cryopreservation Buffer is a medical device manufactured by William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-04-22 under approval number K160814. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by William A. Cook Australia Pty. , Ltd.. The 510(k) number is K160814.

When was Sydney IVF Sperm Cryopreservation Buffer approved by the FDA?

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

What company makes Sydney IVF Sperm Cryopreservation Buffer?

Sydney IVF Sperm Cryopreservation Buffer is manufactured by William A. Cook Australia Pty. , Ltd..

What is the FDA product code for Sydney IVF Sperm Cryopreservation Buffer?

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

Other Devices by William A. Cook Australia Pty. , Ltd.

K153478Sydney IVF Gamete Buffer K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit K151367Sydney IVF Hyaluronidase K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium K171611Double Lumen Ovum Aspiration Needles K160753COOK Vacuum Pump

View all 9 devices →

Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd. K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty. , Ltd. K160863PBS(-), Phosphate Buffered SalineKitazato Biopharma Co., Ltd. K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashOrigio A/S K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing KitWilliam A. Cook Australia Pty. , Ltd. K152682Sydney IVF Cryopreservation Kit, Sydney IVF Thawing KitWillian A. Cook Australia Pty, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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