The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Campylobacter Selective Supplement (bl.).
| Device ID | K802753 |
| 510k Number | K802753 |
| Device Name: | CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) |
| 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 | 1980-11-03 |
| Decision Date | 1980-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05032384011674 | K802753 | 000 |