K233349
- 510(k) number
- K233349
- Device name
- Alinity m HSV 1 & 2 / VZV
- Applicant
- Abbott Molecular, Inc. IL · US
- Product code
- PGI — Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay
- Decision date
- 2024-05-03
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233349.pdf
Official FDA record: K233349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.