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FDA 510(k), K103175, FILMARRAY RESPIRATORY PANEL (RP)
FDA 510(k), K103175, FILMARRAY RESPIRATORY PANEL (RP)
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510(K) Number: K103175
Device Name: FILMARRAY RESPIRATORY PANEL (RP)
Manufacturer: IDAHO TECHNOLOGY, INC.
Device Classification Name: respiratory virus panel nucleic acid assay system
Regulation Number: 866.3980
Classification Product Code: OCC
Date Received: 10/28/2010
Decision Date: 02/17/2011
Regulation Medical Specialty: Microbiology
Device Name: FILMARRAY RESPIRATORY PANEL (RP)
Manufacturer: IDAHO TECHNOLOGY, INC.
Device Classification Name: respiratory virus panel nucleic acid assay system
Regulation Number: 866.3980
Classification Product Code: OCC
Date Received: 10/28/2010
Decision Date: 02/17/2011
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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