Lyra Influenza A+B Assay— 510(k) K230236
Substantially EquivalentQuidel Corporation
FDA 510(k) clearance K230236 for Lyra Influenza A+B Assay, Substantially Equivalent on 2023-03-03. Applicant: Quidel Corporation. Device class: 2.
Clearance details
- Applicant
- Quidel Corporation
- Product code
- Code OZE
- Device class
- Class 2
- Regulation
- 21 CFR 866.3980
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code OZE
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- K220801 — ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2
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More clearances from Quidel Corporation
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- K230349 — Lyra RSV+hMPV Assay
- DEN220039 — Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
Data sourced from openFDA. This site is unofficial and independent of the FDA.