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FDA 510(k), K132750, ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
FDA 510(k), K132750, ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
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$149.00 USD
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$149.00 USD
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510(K) Number: K132750
Device Name: ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
Manufacturer:
Device Classification Name: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Regulation Number: 866.5900
Classification Product Code: PFS
Date Received: 09/03/2013
Decision Date: 11/19/2013
Regulation Medical Specialty: Immunology
Device Name: ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
Manufacturer:
Device Classification Name: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Regulation Number: 866.5900
Classification Product Code: PFS
Date Received: 09/03/2013
Decision Date: 11/19/2013
Regulation Medical Specialty: Immunology
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