The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Lyfo Kwik(tm) Rus Kit.
| Device ID | K870731 |
| 510k Number | K870731 |
| Device Name: | LYFO KWIK(TM) RUS KIT |
| Classification | Kit, Screening, Urine |
| 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 | JXA |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-25 |
| Decision Date | 1987-06-17 |