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FDA 510(k)

Sydney IVF Hyaluronidase

K-Number: K151367 · 2016-01-27

ApplicantWilliam A. Cook Australia Pty. , Ltd.
Decision Date2016-01-27
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Sydney IVF Hyaluronidase is a medical device manufactured by William A. Cook Australia Pty. , Ltd.. It received FDA 510(k) clearance on 2016-01-27 under approval number K151367. 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 Hyaluronidase?

Sydney IVF Hyaluronidase is a medical device that received FDA 510(k) clearance on 2016-01-27. It is manufactured by William A. Cook Australia Pty. , Ltd.. The 510(k) number is K151367.

When was Sydney IVF Hyaluronidase approved by the FDA?

Sydney IVF Hyaluronidase received FDA 510(k) clearance on 2016-01-27, under approval number K151367.

What company makes Sydney IVF Hyaluronidase?

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

What is the FDA product code for Sydney IVF Hyaluronidase?

The FDA product code for Sydney IVF Hyaluronidase is MQL.

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

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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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