510(k) K850963

DUPONT PREP TYPE SI EXTRACITON CARTRIDGE by E.I. Dupont DE Nemours & Co., Inc. — Product Code DJY

K850963 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT PREP TYPE SI EXTRACITON CARTRIDGE". The FDA issued a decision of Substantially Equivalent on March 25, 1985. 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
March 25, 1985
Date Received
March 8, 1985
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