The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Gas Generating Kit System For Campylob..
| Device ID | K802494 |
| 510k Number | K802494 |
| Device Name: | GAS GENERATING KIT SYSTEM FOR CAMPYLOB. |
| Classification | Device, Gas Generating |
| Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-10 |
| Decision Date | 1980-11-12 |