The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Complement-fixation Test For Campylobacter Jejuni.
| Device ID | K862814 |
| 510k Number | K862814 |
| Device Name: | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI |
| Classification | Campylobacter Spp. |
| Applicant | INSTITUTE VIRION LTD. WEINGARTENSTRASSE 9, POSTFACH CH-8803 RUSCHLIKON Zurich, Switzerland, CH |
| Contact | Edwin H Lennette,md |
| Correspondent | Edwin H Lennette,md INSTITUTE VIRION LTD. WEINGARTENSTRASSE 9, POSTFACH CH-8803 RUSCHLIKON Zurich, Switzerland, CH |
| Product Code | LQP |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-24 |
| Decision Date | 1986-09-30 |