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FDA 510(k)

Sydney IVF Gamete Buffer

K-Number: K153478 · 2016-08-15

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2016-08-15
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sydney IVF Gamete Buffer is a medical device manufactured by William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-08-15 under approval number K153478. 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 Gamete Buffer?

Sydney IVF Gamete Buffer is a medical device that received FDA 510(k) clearance on 2016-08-15. It is manufactured by William A. Cook Australia Pty. , Ltd.. The 510(k) number is K153478.

When was Sydney IVF Gamete Buffer approved by the FDA?

Sydney IVF Gamete Buffer received FDA 510(k) clearance on 2016-08-15, under approval number K153478.

What company makes Sydney IVF Gamete Buffer?

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

What is the FDA product code for Sydney IVF Gamete Buffer?

The FDA product code for Sydney IVF Gamete Buffer is MQL.

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Related Devices (Code: MQL)

K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., 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. K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw Oocytes, Embryos and PN zygotes Vitrification Thaw KitIrvine Scientific

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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