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FDA 510(k), K193419, MBT Sepsityper
FDA 510(k), K193419, MBT Sepsityper
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510(K) Number: K193419
Device Name: MBT Sepsityper
Manufacturer: Bruker Daltonik GmbH
Device Classification Name: Mass Spectrometry, Microorganism Identification, Blood Culture
Regulation Number:
Classification Product Code: QNJ
Date Received: 12/09/2019
Decision Date: 12/27/2020
Regulation Medical Specialty: Microbiology
Device Name: MBT Sepsityper
Manufacturer: Bruker Daltonik GmbH
Device Classification Name: Mass Spectrometry, Microorganism Identification, Blood Culture
Regulation Number:
Classification Product Code: QNJ
Date Received: 12/09/2019
Decision Date: 12/27/2020
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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