ARK Lacosamide Assay— 510(k) K201089
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K201089 for ARK Lacosamide Assay, Substantially Equivalent on 2021-08-05. Applicant: Ark Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code NWM
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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More clearances from Ark Diagnostics, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.