K833320 is an FDA 510(k) clearance for the AMBERLITE CG50 RESIN, 100-200 MESH. This device is classified as a Resins, Ion-exchange (Class I - General Controls, product code KEA).
Submitted by Biosan Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1983, 73 days after receiving the submission on September 26, 1983.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K833320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1983 |
| Decision Date | December 08, 1983 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KEA — Resins, Ion-exchange |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |