FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
K Number: K223591
·
Decision Jul 27, 2023
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
32
Applicant Total
51
Review Days
238
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Basic Information
- Device Name
- cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- K Number
- K223591
- Device Class
- FDA class 2
- Clearance Type
- Dual Track
- Regulation Number
- 866.3981
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Molecular Systems, Inc.
- Date Received
- December 1, 2022
- Decision Date
- July 27, 2023
- Product Code
- QOF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | FDA class 2 | Microbiology |
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