K832198 is an FDA 510(k) clearance for the HC40/HC75 PREPACKED COLUMS. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Hamilton Co. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 36 days after receiving the submission on July 7, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K832198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1983 |
| Decision Date | August 12, 1983 |
| Days to Decision | 36 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 |