ARK Methotrexate II Assay— 510(k) K232017
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K232017 for ARK Methotrexate II Assay, Substantially Equivalent on 2023-12-20. Applicant: Ark Diagnostics, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- Ark Diagnostics, Inc.
- Product code
- Code LAO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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