K831289 is an FDA 510(k) clearance for the PREFILLED IEC COLUMNS. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Berwick Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1983, 57 days after receiving the submission on April 20, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K831289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1983 |
| Decision Date | June 16, 1983 |
| Days to Decision | 57 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 |