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 |