The following data is part of a premarket notification filed by Institute Virion Ltd. with the FDA for Campylocacter Supplement.
| Device ID | K843653 |
| 510k Number | K843653 |
| Device Name: | CAMPYLOCACTER SUPPLEMENT |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | INSTITUTE VIRION LTD. 6605 ASCOT DR. Oakland, CA 94611 |
| Contact | Edwin H Lennette |
| Correspondent | Edwin H Lennette INSTITUTE VIRION LTD. 6605 ASCOT DR. Oakland, CA 94611 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-17 |
| Decision Date | 1984-10-23 |