The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Listeria Selective Medium (oxford Formulation).
Device ID | K884208 |
510k Number | K884208 |
Device Name: | LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) |
Classification | Culture Media, Enriched |
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 | KZI |
CFR Regulation Number | 866.2330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-06 |
Decision Date | 1988-10-25 |