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FDA 510(k)

BGM GALECTIN -3

K-Number: K093758 · 2010-11-17

ApplicantBg Medicine, Inc.
Decision Date2010-11-17
Product CodeOSX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BGM GALECTIN -3 is the device name listed in this FDA 510(k) record. The listed applicant is Bg Medicine, Inc.. It received FDA 510(k) clearance on 2010-11-17 under 510(k) number K093758. The device is classified under product code OSX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BGM GALECTIN -3?

BGM GALECTIN -3 is a medical device that received FDA 510(k) clearance on 2010-11-17. The listed applicant is Bg Medicine, Inc.. The 510(k) number is K093758.

When did BGM GALECTIN -3 receive FDA 510(k) clearance?

BGM GALECTIN -3 received FDA 510(k) clearance on 2010-11-17, under 510(k) number K093758.

Who is the listed applicant for BGM GALECTIN -3?

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

What is the FDA product code for BGM GALECTIN -3?

The FDA product code for BGM GALECTIN -3 is OSX.

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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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