Cleared Traditional

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

K232201 · bioMerieux, Inc. · Microbiology

Oct 2023

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K232201 is an FDA 510(k) clearance for the VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 ?g/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 ?g/mL), VITEK 2 Streptococcus Penicillin, a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II — Special Controls, product code LON), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 23, 2023, 90 days after receiving the submission on July 25, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K232201 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2023
Decision Date	October 23, 2023
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.1645