K243498
- 510(k) number
- K243498
- Device name
- Alinity c Benzodiazepines Reagent Kit
- Applicant
- Microgenics Corporation CA · US
- Product code
- JXM — Enzyme Immunoassay, Benzodiazepine
- Decision date
- 2024-12-11
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243498.pdf
Official FDA record: K243498
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.