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510(k) K243346

Device
cobas liat SARS-CoV-2 v2 nucleic acid test
Applicant
Roche Molecular Systems, Inc.
510(k) number
K243346
Product code
QWR
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-11
Date received
2024-10-28
Regulation
866.3982
Classification name
Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Deborah Leu
Address
4300 Hacienda Dr. Pleasanton CA US 94588 94588

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QWR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223783cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.2023-12-04
K221925ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.2023-08-10