K240670
- 510(k) number
- K240670
- Device name
- DRI Ecstasy Plus Assay
- Applicant
- Microgenics Corporation CA · US
- Product code
- DKZ — Enzyme Immunoassay, Amphetamine
- Decision date
- 2024-10-30
- Date received
- 2024-03-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K240670.pdf
Official FDA record: K240670
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.