The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Lyfo-kwik Omi Kit.
| Device ID | K851978 |
| 510k Number | K851978 |
| Device Name: | LYFO-KWIK OMI KIT |
| Classification | Kit, Identification, Enterobacteriaceae |
| 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 | JSS |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-07 |
| Decision Date | 1985-06-04 |