510(k) K261867

Device

Xpert Carba-R

Applicant

Cepheid®

510(k) number

K261867

Product code

POC

Decision

Substantially Equivalent (SESE)

Decision date

2026-07-02

Date received

2026-06-04

Regulation

866.1640

Classification name

System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Medical specialty

Microbiology

Review panel

Microbiology

Device class

2

Clearance type

Special

Statement or summary

Summary

Third party reviewed

N