510(k) K823697

PREP TYPE A EXTRACTION CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DJY

K823697 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "PREP TYPE A EXTRACTION CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 5, 1983. The device falls under product code DJY (Ion-Exchange Chromatography), a Class I device regulated under 21 CFR 862.2230. 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 5, 1983
Date Received
December 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ion-Exchange Chromatography
Device Class
Class I
Regulation Number
862.2230
Review Panel
TX
Submission Type