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FDA 510(k), K140407, FILMARRAY GASTROINTESTINAL (GI) PANEL
FDA 510(k), K140407, FILMARRAY GASTROINTESTINAL (GI) PANEL
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510(K) Number: K140407
Device Name: FILMARRAY GASTROINTESTINAL (GI) PANEL
Manufacturer: BETH LINGENFELTER
Device Classification Name: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Regulation Number: PCH
Classification Product Code: KXA
Date Received: 02/18/2014
Decision Date: 05/02/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: FILMARRAY GASTROINTESTINAL (GI) PANEL
Manufacturer: BETH LINGENFELTER
Device Classification Name: Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Regulation Number: PCH
Classification Product Code: KXA
Date Received: 02/18/2014
Decision Date: 05/02/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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