K232775
- 510(k) number
- K232775
- Device name
- ID NOW Influenza A & B 2
- Applicant
- Abbott Diagnostics Scarborough, Inc. ME · US
- Product code
- OCC — Respiratory Virus Panel Nucleic Acid Assay System
- Decision date
- 2023-10-10
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K232775.pdf
Official FDA record: K232775
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.