K863245 is an FDA 510(k) clearance for the SYVA ETS SYSTEM. This device is classified as a Analyzer, Chemistry, Micro, For Clinical Use (Class I - General Controls, product code JJF).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on March 13, 1987, 203 days after receiving the submission on August 22, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2170.
| 510(k) Number | K863245 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1986 |
| Decision Date | March 13, 1987 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JJF — Analyzer, Chemistry, Micro, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2170 |