Cleared Traditional

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin

K230864 · bioMerieux, Inc. · Microbiology

Jul 2023

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K230864 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 ?g/mL), VITEK 2 AST-GP Daptomycin, 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 July 5, 2023, 98 days after receiving the submission on March 29, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1645.

Submission Details

510(k) Number	K230864 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 2023
Decision Date	July 05, 2023
Days to Decision	98 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