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FDA 510(k), K190784, BUHLMANN fCAL turbo
FDA 510(k), K190784, BUHLMANN fCAL turbo
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510(K) Number: K190784
Device Name: BUHLMANN fCAL turbo
Manufacturer: BUHLMANN Laboratories AG
Device Classification Name: calprotectin, fecal
Regulation Number: 866.5180
Classification Product Code: NXO
Date Received: 03/27/2019
Decision Date: 06/25/2019
Regulation Medical Specialty: Immunology
Device Name: BUHLMANN fCAL turbo
Manufacturer: BUHLMANN Laboratories AG
Device Classification Name: calprotectin, fecal
Regulation Number: 866.5180
Classification Product Code: NXO
Date Received: 03/27/2019
Decision Date: 06/25/2019
Regulation Medical Specialty: Immunology
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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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