K232286
- 510(k) number
- K232286
- Device name
- Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument
- Applicant
- Quidel Corporation CA · US
- Product code
- PGI — Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay
- Decision date
- 2023-12-20
- Date received
- 2023-08-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K232286.pdf
Official FDA record: K232286
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.