510(k) K111904
K111904 is an FDA 510(k) premarket notification submitted by Ark Diagnostics, Inc. for the device "ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN". The FDA issued a decision of Substantially Equivalent on October 18, 2011. 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
- October 18, 2011
- Date Received
- July 5, 2011
- 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