VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K-Number: K163006 · 2017-01-24
ApplicantbioMerieux, Inc.
Decision Date2017-01-24
Product CodeLON
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-01-24 under approval number K163006. 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 Tigecycline (<0.5->8 ug/mL)?
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) is a medical device that received FDA 510(k) clearance on 2017-01-24. It is manufactured by bioMerieux, Inc.. The 510(k) number is K163006.
When was VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) approved by the FDA?
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) received FDA 510(k) clearance on 2017-01-24, under approval number K163006.
What company makes VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)?
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) is manufactured by bioMerieux, Inc..
What is the FDA product code for VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)?
The FDA product code for VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) is LON.
Other Devices by bioMerieux, Inc.
Related Devices (Code: LON)
K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)bioMerieux, Inc.
K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)bioMerieux, Inc.
K151320BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/mlBecton, Dickinson and Company
K172944VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 >=16 µg/mLbioMerieux, Inc.
K172731VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)bioMerieux, Inc.
K162737VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)bioMerieux, Inc.
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.