VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
K-Number: K172731 · 2017-12-08
ApplicantbioMerieux, Inc.
Decision Date2017-12-08
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-12-08 under approval number K172731. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)?
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) is a medical device that received FDA 510(k) clearance on 2017-12-08. It is manufactured by bioMerieux, Inc.. The 510(k) number is K172731.
When was VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) approved by the FDA?
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) received FDA 510(k) clearance on 2017-12-08, under approval number K172731.
What company makes VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)?
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) is manufactured by bioMerieux, Inc..
What is the FDA product code for VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)?
The FDA product code for VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) is LON.
Other Devices by bioMerieux, Inc.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.