FDA.report

510(k) K243455

Device
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
Applicant
Roche Molecular Systems, Inc.
510(k) number
K243455
Product code
QOF
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-31
Date received
2024-11-07
Regulation
866.3981
Classification name
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Claudia Machay
Address
4300 Hacienda Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers

Source Documents

510(k) summary PDF

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