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FDA 510(k)

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium

K-Number: K153290 · 2016-01-27

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

Device Summary

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium 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 K153290. 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 Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium?

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium 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 K153290.

When was Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium approved by the FDA?

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium received FDA 510(k) clearance on 2016-01-27, under approval number K153290.

What company makes Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium?

Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium is manufactured by William A. Cook Australia Pty. , Ltd..

What is the FDA product code for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium?

The FDA product code for Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage Medium, Sydney IVF Blastocyst Medium is MQL.

Related Clinical Trials

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

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

K153478Sydney IVF Gamete Buffer K152717Sydney IVF Blastocyst Cryopreservation Kit, Sydney IVF Blastocyst Thawing Kit K160814Sydney IVF Sperm Cryopreservation Buffer K151367Sydney IVF Hyaluronidase K171611Double Lumen Ovum Aspiration Needles K160753COOK Vacuum Pump

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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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