K231020
- 510(k) number
- K231020
- Device name
- Alinity c Tricyclic Antidepressants Reagent Kit
- Applicant
- Microgenics Corporation CA · US
- Product code
- LFH — U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Decision date
- 2023-11-17
- Date received
- 2023-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K231020.pdf
Official FDA record: K231020
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.