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FDA 510(k), K093758, BGM GALECTIN -3
FDA 510(k), K093758, BGM GALECTIN -3
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510(K) Number: K093758
Device Name: BGM GALECTIN -3
Manufacturer: BG MEDICINE, INC.
Device Classification Name: galectin-3 in vitro diagnostic assay
Regulation Number: 862.1117
Classification Product Code: OSX
Date Received: 12/07/2009
Decision Date: 11/17/2010
Regulation Medical Specialty: Clinical Chemistry
Device Name: BGM GALECTIN -3
Manufacturer: BG MEDICINE, INC.
Device Classification Name: galectin-3 in vitro diagnostic assay
Regulation Number: 862.1117
Classification Product Code: OSX
Date Received: 12/07/2009
Decision Date: 11/17/2010
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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