The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Kwi (tm) G-co/two.
| Device ID | K855172 |
| 510k Number | K855172 |
| Device Name: | KWI (TM) G-CO/TWO |
| Classification | Supplement, Culture Media |
| Applicant | MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Contact | Oerald Tjernagel |
| Correspondent | Oerald Tjernagel MICRO-BIO-LOGICS 217 OSSEO AVENUE NORTH St. Cloud, MN 56301 |
| Product Code | JSK |
| CFR Regulation Number | 866.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-26 |
| Decision Date | 1986-02-20 |