K850659 is an FDA 510(k) clearance for the SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER. This device is classified as a Calculator/data Processing Module, For Clinical Use (Class I - General Controls, product code JQP).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on April 1, 1985, 40 days after receiving the submission on February 20, 1985.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2100.
| 510(k) Number | K850659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1985 |
| Decision Date | April 01, 1985 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JQP — Calculator/data Processing Module, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2100 |