510(k) K884744

ACA DU PONT METHOTREXATE (MTHO) METHOD by E.I. Dupont DE Nemours & Co., Inc. — Product Code LAO

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