cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more— 510(k) K260047
Substantially EquivalentRoche Molecular Systems, Inc.
FDA 510(k) clearance K260047 for cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190) +1 more, Substantially Equivalent on 2026-08-28. Applicant: Roche Molecular Systems, Inc.. Device class: 2.
Clearance details
- Device name as filed
- cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- Applicant
- Roche Molecular Systems, Inc.
- Product code
- Code PGX
- Device class
- Class 2
- Regulation
- 21 CFR 866.2680
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pleasanton, CA, US
Recent devices under product code PGX
view allMore clearances from Roche Molecular Systems, Inc.
view all- K260045 — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190) +1 more
- K260021 — cobas® BV/CV
- K260917 — cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
- K253756 — cobas liat CT/NG nucleic acid test
- K253759 — cobas liat CT/NG/MG nucleic acid test
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