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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: 02/18/2014
Date Received: 05/02/2014
Decision Date: 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: 02/18/2014
Date Received: 05/02/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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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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