The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Biocult - Gc Culture-paddles.
| Device ID | K831124 |
| 510k Number | K831124 |
| Device Name: | BIOCULT - GC CULTURE-PADDLES |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | ORION DIAGNOSTICA, 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 | 1983-04-05 |
| Decision Date | 1983-05-09 |