K883615 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Supelco, Inc. (Bellefonte, US). The FDA issued a Cleared decision on December 16, 1988, 114 days after receiving the submission on August 24, 1988.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K883615 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1988 |
| Decision Date | December 16, 1988 |
| Days to Decision | 114 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 |