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 |