The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Ono/co-two (tm) Systems.
| Device ID | K844014 |
| 510k Number | K844014 |
| Device Name: | ONO/CO-TWO (TM) SYSTEMS |
| Classification | Culture Media, For Isolation Of Pathogenic Neisseria |
| Applicant | MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Contact | Gerald Tjernagel |
| Correspondent | Gerald Tjernagel MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Product Code | JTY |
| CFR Regulation Number | 866.2410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-12 |
| Decision Date | 1984-10-31 |