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FDA 510(k)

HBA SPERM-HYALURONAN BINDING ASSAY

K-Number: K032874 · 2003-11-24

ApplicantBiocoat, Inc.
Decision Date2003-11-24
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBA SPERM-HYALURONAN BINDING ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biocoat, Inc.. It received FDA 510(k) clearance on 2003-11-24 under 510(k) number K032874. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBA SPERM-HYALURONAN BINDING ASSAY?

HBA SPERM-HYALURONAN BINDING ASSAY is a medical device that received FDA 510(k) clearance on 2003-11-24. The listed applicant is Biocoat, Inc.. The 510(k) number is K032874.

When did HBA SPERM-HYALURONAN BINDING ASSAY receive FDA 510(k) clearance?

HBA SPERM-HYALURONAN BINDING ASSAY received FDA 510(k) clearance on 2003-11-24, under 510(k) number K032874.

Who is the listed applicant for HBA SPERM-HYALURONAN BINDING ASSAY?

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 HBA SPERM-HYALURONAN BINDING ASSAY?

The FDA product code for HBA SPERM-HYALURONAN BINDING ASSAY is POV.

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.

K052457PICSI SPERM SELECTION DEVICE

Related Devices (Code: POV)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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