510(k) K830398
K830398 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "TDX METHOTREXATE". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1983
- Date Received
- February 7, 1983
- 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