The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Sterile Gc Supplement (w/o Antibiotics).
| Device ID | K800255 |
| 510k Number | K800255 |
| Device Name: | STERILE GC SUPPLEMENT (W/O ANTIBIOTICS) |
| 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 | 1980-02-06 |
| Decision Date | 1980-03-12 |