ARK Fentanyl II Assay— 510(k) K200197
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K200197 for ARK Fentanyl II Assay, Substantially Equivalent on 2020-02-26. Applicant: Ark Diagnostics, Inc..
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- 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.