K850963 is an FDA 510(k) clearance for the DUPONT PREP TYPE SI EXTRACITON CARTRIDGE. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on March 25, 1985, 17 days after receiving the submission on March 8, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K850963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1985 |
| Decision Date | March 25, 1985 |
| Days to Decision | 17 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DJY — Ion-exchange Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |