Cleared Traditional

K232201 - VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (FDA 510(k) Clearance)

K232201 · bioMerieux, Inc. · Microbiology device

Oct 2023

Decision

90d

Days

Class 2

Risk

K232201 is an FDA 510(k) clearance for the VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K232201 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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