The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Clostridium Difficile Agar Base.
| Device ID | K802495 |
| 510k Number | K802495 |
| Device Name: | CLOSTRIDIUM DIFFICILE 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 | 1980-10-10 |
| Decision Date | 1980-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384003648 | K802495 | 000 |