510(k) K884744
K884744 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA DU PONT METHOTREXATE (MTHO) METHOD". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1989
- Date Received
- November 14, 1988
- 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