ARK Methotrexate Assay— 510(k) K163359
Substantially EquivalentArk Diagnostics, Inc.
FDA 510(k) clearance K163359 for ARK Methotrexate Assay, Substantially Equivalent on 2017-08-18. 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
- Special
- Location
- Fremont, CA, US
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