510(k) K792584

ACA ETHOSURIMIDE TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code DLF

K792584 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA ETHOSURIMIDE TEST PACK". The FDA issued a decision of Substantially Equivalent on December 31, 1979. The device falls under product code DLF (Enzyme Immunoassay, Ethosuximide), a Class II device regulated under 21 CFR 862.3380. 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
December 31, 1979
Date Received
December 14, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Ethosuximide
Device Class
Class II
Regulation Number
862.3380
Review Panel
TX
Submission Type