510(k) K240197 · QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
cobas® liat CT/NG/MG nucleic acid test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 16, 2025 |
| Received | Jan 25, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K240197
No recall in the FDA data names this 510(k).
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