The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Perfringens Supplement B.
Device ID | K800263 |
510k Number | K800263 |
Device Name: | PERFRINGENS SUPPLEMENT B |
Classification | Supplement, Culture Media |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSK |
CFR Regulation Number | 866.2450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-06 |
Decision Date | 1980-03-12 |