510(k) K895043— COMA COCAINE METABOLITE ASSAY (EIA)
Substantially EquivalentSerex, Inc.
Clearance details
- Applicant
- Serex, Inc.
- Product code
- Code DIO
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tenafly, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.