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FDA 510(k)

MODIFICATION TO BVBLUE

K-Number: K050755 · 2005-04-06

ApplicantGryphus Diagnostics, LLC
Decision Date2005-04-06
Product CodeMXB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO BVBLUE is the device name listed in this FDA 510(k) record. The listed applicant is Gryphus Diagnostics, LLC. It received FDA 510(k) clearance on 2005-04-06 under 510(k) number K050755. The device is classified under product code MXB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO BVBLUE?

MODIFICATION TO BVBLUE is a medical device that received FDA 510(k) clearance on 2005-04-06. The listed applicant is Gryphus Diagnostics, LLC. The 510(k) number is K050755.

When did MODIFICATION TO BVBLUE receive FDA 510(k) clearance?

MODIFICATION TO BVBLUE received FDA 510(k) clearance on 2005-04-06, under 510(k) number K050755.

Who is the listed applicant for MODIFICATION TO BVBLUE?

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

What is the FDA product code for MODIFICATION TO BVBLUE?

The FDA product code for MODIFICATION TO BVBLUE is MXB.

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 Gryphus Diagnostics, LLC 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.

K993732BVBLUE

Related Devices (Code: MXB)

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.

K993732BVBLUEGryphus Diagnostics, LLC

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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