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FDA 510(k), K172731, VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
FDA 510(k), K172731, VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
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510(K) Number: K172731
Device Name: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
Manufacturer: bioMerieux, Inc.
Device Classification Name: system, test, automated, antimicrobial susceptibility, short incubation
Regulation Number: 866.1645
Classification Product Code: LON
Date Received: 09/11/2017
Decision Date: 12/08/2017
Regulation Medical Specialty: Microbiology
Device Name: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
Manufacturer: bioMerieux, Inc.
Device Classification Name: system, test, automated, antimicrobial susceptibility, short incubation
Regulation Number: 866.1645
Classification Product Code: LON
Date Received: 09/11/2017
Decision Date: 12/08/2017
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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