The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Listeria Selective Enrichment Medium.
| Device ID | K891593 |
| 510k Number | K891593 |
| Device Name: | LISTERIA SELECTIVE ENRICHMENT MEDIUM |
| Classification | Culture Media, Selective And Differential |
| Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Maryalice Francisco |
| Correspondent | Maryalice Francisco OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JSI |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-06-09 |