The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Campylobacter Agar Base.
Device ID | K840332 |
510k Number | K840332 |
Device Name: | CAMPYLOBACTER AGAR BASE |
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 | 1984-01-25 |
Decision Date | 1984-05-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05032384003877 | K840332 | 000 |