The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Cooked Meat Medium.
Device ID | K813232 |
510k Number | K813232 |
Device Name: | COOKED MEAT MEDIUM |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-11-17 |
Decision Date | 1981-12-03 |