The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Brucella Agar.
Device ID | K833886 |
510k Number | K833886 |
Device Name: | BRUCELLA AGAR |
Classification | Culture Media, Selective And Non-differential |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-09 |
Decision Date | 1983-12-12 |