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FDA 510(k), K083845, XTAG CF60 KIT V2
FDA 510(k), K083845, XTAG CF60 KIT V2
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510(K) Number: K083845
Device Name: XTAG CF60 KIT V2
Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS, INC.
Device Classification Name: system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
Regulation Number: 866.5900
Classification Product Code: NUA
Date Received: 12/24/2008
Decision Date: 12/11/2009
Regulation Medical Specialty: Immunology
Device Name: XTAG CF60 KIT V2
Manufacturer: LUMINEX MOLECULAR DIAGNOSTICS, INC.
Device Classification Name: system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
Regulation Number: 866.5900
Classification Product Code: NUA
Date Received: 12/24/2008
Decision Date: 12/11/2009
Regulation Medical Specialty: Immunology
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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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