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FDA 510(k)

Arctic Sperm Cryopreservation Medium

K-Number: K171224 · 2017-08-31

ApplicantIrvine Scientific Sales Co., Inc.
Decision Date2017-08-31
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Arctic Sperm Cryopreservation Medium is a medical device manufactured by Irvine Scientific Sales Co., Inc.. It received FDA 510(k) clearance on 2017-08-31 under approval number K171224. 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 Arctic Sperm Cryopreservation Medium?

Arctic Sperm Cryopreservation Medium is a medical device that received FDA 510(k) clearance on 2017-08-31. It is manufactured by Irvine Scientific Sales Co., Inc.. The 510(k) number is K171224.

When was Arctic Sperm Cryopreservation Medium approved by the FDA?

Arctic Sperm Cryopreservation Medium received FDA 510(k) clearance on 2017-08-31, under approval number K171224.

What company makes Arctic Sperm Cryopreservation Medium?

Arctic Sperm Cryopreservation Medium is manufactured by Irvine Scientific Sales Co., Inc..

What is the FDA product code for Arctic Sperm Cryopreservation Medium?

The FDA product code for Arctic Sperm Cryopreservation Medium is MQL.

Related Clinical Trials

NCT07522281 Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles NOT_YET_RECRUITING

Other Devices by Irvine Scientific Sales Co., Inc.

K170681Continuous Single Culture -NX (CSCM-NX) K170602Continuous Single Culture-NX Complete (CSCM-NXC)

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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