K861392 is an FDA 510(k) clearance for the SYVA SOLID PHASE COLUMNS SYSTEM II. This device is classified as a Chromatography (liquid, Gel), Clinical Use (Class I - General Controls, product code KZR).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on June 13, 1986, 60 days after receiving the submission on April 14, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2260.
| 510(k) Number | K861392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1986 |
| Decision Date | June 13, 1986 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | KZR — Chromatography (liquid, Gel), Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2260 |