The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Campylobacter Blood-free Selective Agar Baseq.
| Device ID | K850832 |
| 510k Number | K850832 |
| Device Name: | CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ |
| Classification | Culture Media, Selective And Non-differential |
| Applicant | OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Ruth Kemp |
| Correspondent | Ruth Kemp OXOID U.S.A., INC. 9017 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | JSJ |
| CFR Regulation Number | 866.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-15 |
| Decision Date | 1985-03-29 |