K243575
- 510(k) number
- K243575
- Device name
- ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
- Applicant
- Biokit, S.A. ES
- Product code
- MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Vi
- Decision date
- 2025-02-12
- Date received
- 2024-11-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K243575.pdf
Official FDA record: K243575
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.