K862814 is an FDA 510(k) clearance for the COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI. This device is classified as a Campylobacter Spp. (Class I - General Controls, product code LQP).
Submitted by Institute Virion , Ltd. (Zurich, Switzerland, CH). The FDA issued a Cleared decision on September 30, 1986, 68 days after receiving the submission on July 24, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3110.
| 510(k) Number | K862814 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1986 |
| Decision Date | September 30, 1986 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LQP — Campylobacter Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3110 |