K842028 is an FDA 510(k) clearance for the CM-TRISACRYL M DEAE-TRISACRYL M. This device is classified as a Resins, Ion-exchange (Class I - General Controls, product code KEA).
Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984, 20 days after receiving the submission on May 18, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K842028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 1984 |
| Decision Date | June 07, 1984 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KEA — Resins, Ion-exchange |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |