K840985 is an FDA 510(k) clearance for the TRISACRYL GF 05 & TRISACRYL GF 2000. This device is classified as a Ion-exchange Chromatography (Class I - General Controls, product code DJY).
Submitted by Lkb Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984, 43 days after receiving the submission on March 7, 1984.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2230.
| 510(k) Number | K840985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1984 |
| Decision Date | April 19, 1984 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | DJY — Ion-exchange Chromatography |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2230 |