K833319 is an FDA 510(k) clearance for the BIO-REX 70 RESIN 100-200 MESH PH6.2. 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 November 3, 1983, 38 days after receiving the submission on September 26, 1983.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K833319 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 1983 |
| Decision Date | November 03, 1983 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KEA — Resins, Ion-exchange |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |