K232201

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

510(k) number

K232201

Device name

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

Applicant

bioMerieux, Inc. MO · US

Product code

LON — System, Test, Automated, Antimicrobial Susceptibilit

Decision date

2023-10-23

Date received

2023-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Advisory committee

Microbiology