510(k) K850963
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