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FDA 510(k), K171655, cobas m 511 integrated hematology analyzer
FDA 510(k), K171655, cobas m 511 integrated hematology analyzer
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$149.00 USD
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510(K) Number: K171655
Device Name: cobas m 511 integrated hematology analyzer
Manufacturer: Roche Diagnostics Hematology, Inc.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 06/05/2017
Decision Date: 03/02/2018
Regulation Medical Specialty: Hematology
Device Name: cobas m 511 integrated hematology analyzer
Manufacturer: Roche Diagnostics Hematology, Inc.
Device Classification Name: counter, differential cell
Regulation Number: 864.5220
Classification Product Code: GKZ
Date Received: 06/05/2017
Decision Date: 03/02/2018
Regulation Medical Specialty: Hematology
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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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