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VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)

K213931 Class II Traditional
Decision Date
2022-06-03
Sponsor / Applicant
bioMerieux, Inc.

Technical Specification

510(k) Submission ID K213931
Product Code LON
Medical Specialty / Panel Microbiology
Regulation Citation 21 CFR 866.1645
Decision Date 2022-06-03
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) received FDA 510(k) clearance under submission number K213931, sponsored by bioMerieux, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2022-06-03.

Classification & Regulation

This clearance is catalogued under FDA product code LON and 21 CFR 866.1645, within the Microbiology review panel as a Class II device.