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FDA 510(k)

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

K-Number: K152682 · 2016-05-05

ApplicantWillian A. Cook Australia Pty, Ltd.
Decision Date2016-05-05
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is a medical device manufactured by Willian A. Cook Australia Pty, Ltd.. It received FDA 510(k) clearance on 2016-05-05 under approval number K152682. 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 Cryopreservation Kit, Sydney IVF Thawing Kit?

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Willian A. Cook Australia Pty, Ltd.. The 510(k) number is K152682.

When was Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit approved by the FDA?

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit received FDA 510(k) clearance on 2016-05-05, under approval number K152682.

What company makes Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit?

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is manufactured by Willian A. Cook Australia Pty, Ltd..

What is the FDA product code for Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit?

The FDA product code for Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit is MQL.

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

K171625Single Lumen Ovum Aspiration Needles

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. 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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