The following data is part of a premarket notification filed by Biolog, Inc. with the FDA for Gc Culture Medium.
| Device ID | K811281 |
| 510k Number | K811281 |
| Device Name: | GC CULTURE MEDIUM |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | BIOLOG, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-08 |
| Decision Date | 1981-06-12 |