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FDA 510(k)

CRYOTOP

K-Number: K112695 · 2012-12-12

ApplicantKitazato Biopharma Co;Ltd
Decision Date2012-12-12
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CRYOTOP is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Biopharma Co;Ltd. It received FDA 510(k) clearance on 2012-12-12 under 510(k) number K112695. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOTOP?

CRYOTOP is a medical device that received FDA 510(k) clearance on 2012-12-12. The listed applicant is Kitazato Biopharma Co;Ltd. The 510(k) number is K112695.

When did CRYOTOP receive FDA 510(k) clearance?

CRYOTOP received FDA 510(k) clearance on 2012-12-12, under 510(k) number K112695.

Who is the listed applicant for CRYOTOP?

The FDA 510(k) record lists Kitazato Biopharma Co;Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRYOTOP?

The FDA product code for CRYOTOP is MQK.

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Other records listing Kitazato Biopharma Co;Ltd as applicant

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Related Devices (Code: MQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, 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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