510(k) clearance
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190)
- 510(k) number
- K260047
- Applicant
- Roche Molecular Systems, Inc.
- Decision date
- Aug 28, 2026
- Date received
- Jan 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PGX
- Device type
- Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Device class
- Class II
- Regulation
- 21 CFR 866.2680
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Pleasanton, CA, US