K890113 is an FDA 510(k) clearance for the THE CDI(R) SYSTEM 400. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on May 23, 1989, 132 days after receiving the submission on January 11, 1989.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K890113 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 1989 |
| Decision Date | May 23, 1989 |
| Days to Decision | 132 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 |