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FDA 510(k), K153661, ImmunoCard STAT! HpSA
FDA 510(k), K153661, ImmunoCard STAT! HpSA
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510(K) Number: K153661
Device Name: ImmunoCard STAT! HpSA
Manufacturer: Meridian Bioscience, Inc
Device Classification Name: helicobacter pylori
Regulation Number: 866.3110
Classification Product Code: LYR
Date Received: 12/21/2015
Decision Date: 03/14/2016
Regulation Medical Specialty: Microbiology
Device Name: ImmunoCard STAT! HpSA
Manufacturer: Meridian Bioscience, Inc
Device Classification Name: helicobacter pylori
Regulation Number: 866.3110
Classification Product Code: LYR
Date Received: 12/21/2015
Decision Date: 03/14/2016
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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