K212769
- 510(k) number
- K212769
- Device name
- DYNEX SmartPLEX MMRV IgG Assay Kit
- Applicant
- Dynex Technologies, Inc. VA · US
- Product code
- OPL — Multiplex Immunoassay For Measles Virus, Mumps Virus
- Decision date
- 2023-09-29
- Date received
- 2021-08-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K212769.pdf
Official FDA record: K212769
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.