CEDIA Heroin Metabolite (6-AM) Assay— 510(k) K231007
Substantially EquivalentMicrogenics Corporation
FDA 510(k) clearance K231007 for CEDIA Heroin Metabolite (6-AM) Assay, Substantially Equivalent on 2023-09-27. Applicant: Microgenics Corporation.
Clearance details
- Applicant
- Microgenics Corporation
- Product code
- Code DJG
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.