510(k) K232017
K232017 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK Methotrexate II Assay". The FDA issued a decision of Substantially Equivalent on December 20, 2023. 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
- December 20, 2023
- Date Received
- July 7, 2023
- Clearance Type
- Traditional
- 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