K213987
- 510(k) number
- K213987
- Device name
- ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
- Applicant
- Biokit, S.A. ES
- Product code
- MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Vi
- Decision date
- 2023-09-20
- Date received
- 2021-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K213987.pdf
Official FDA record: K213987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.