K231007
- 510(k) number
- K231007
- Device name
- CEDIA Heroin Metabolite (6-AM) Assay
- Applicant
- Microgenics Corporation CA · US
- Product code
- DJG — Enzyme Immunoassay, Opiates
- Decision date
- 2023-09-27
- Date received
- 2023-04-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231007.pdf
Official FDA record: K231007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.