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FDA 510(k)

PICSI SPERM SELECTION DEVICE

K-Number: K052457 · 2006-04-13

ApplicantBiocoat, Inc.
Decision Date2006-04-13
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PICSI SPERM SELECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Biocoat, Inc.. It received FDA 510(k) clearance on 2006-04-13 under 510(k) number K052457. 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 PICSI SPERM SELECTION DEVICE?

PICSI SPERM SELECTION DEVICE is a medical device that received FDA 510(k) clearance on 2006-04-13. The listed applicant is Biocoat, Inc.. The 510(k) number is K052457.

When did PICSI SPERM SELECTION DEVICE receive FDA 510(k) clearance?

PICSI SPERM SELECTION DEVICE received FDA 510(k) clearance on 2006-04-13, under 510(k) number K052457.

Who is the listed applicant for PICSI SPERM SELECTION DEVICE?

The FDA 510(k) record lists Biocoat, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICSI SPERM SELECTION DEVICE?

The FDA product code for PICSI SPERM SELECTION DEVICE is MQK.

Related Clinical Trials

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.

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Other records listing Biocoat, Inc. as applicant

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.

K032874HBA SPERM-HYALURONAN BINDING ASSAY

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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