510(k) K163359
K163359 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK Methotrexate Assay". The FDA issued a decision of Substantially Equivalent on August 18, 2017. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. Ark Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2017
- Date Received
- November 30, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Methotrexate
- Device Class
- Class U
- Regulation Number
- Review Panel
- TX
- Submission Type