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FDA 510(k), K191718, Buhlmann fCAL turbo and CALEX Cap
FDA 510(k), K191718, Buhlmann fCAL turbo and CALEX Cap
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$149.00 USD
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510(K) Number: K191718
Device Name: Buhlmann fCAL turbo and CALEX Cap
Manufacturer: BUHLMANN Laboratories AG
Device Classification Name: calprotectin, fecal
Regulation Number: 866.5180
Classification Product Code: NXO
Date Received: 06/26/2019
Decision Date: 09/24/2019
Regulation Medical Specialty: Immunology
Device Name: Buhlmann fCAL turbo and CALEX Cap
Manufacturer: BUHLMANN Laboratories AG
Device Classification Name: calprotectin, fecal
Regulation Number: 866.5180
Classification Product Code: NXO
Date Received: 06/26/2019
Decision Date: 09/24/2019
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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