K231214
- 510(k) number
- K231214
- Device name
- LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
- Applicant
- DiaSorin, Inc. MN · US
- Product code
- LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoste
- Decision date
- 2023-10-27
- Date received
- 2023-04-28
- 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: K231214.pdf
Official FDA record: K231214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.