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FDA 510(k), K083846, XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
FDA 510(k), K083846, XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
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510(K) Number: K083846
Device Name: XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
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: 09/01/2009
Regulation Medical Specialty: Immunology
Device Name: XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267
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: 09/01/2009
Regulation Medical Specialty: Immunology
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