The following data is part of a premarket notification filed by Micro Bio Logics, Inc. with the FDA for Lyfo(tm) Differential Disk-bile.
| Device ID | K945882 |
| 510k Number | K945882 |
| Device Name: | LYFO(TM) DIFFERENTIAL DISK-BILE |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | MICRO BIO LOGICS, INC. 217 OSSEO AVE. NORTH St. Cloud, MN 56303 -4452 |
| Contact | Geri Hotz |
| Correspondent | Geri Hotz MICRO BIO LOGICS, INC. 217 OSSEO AVE. NORTH St. Cloud, MN 56303 -4452 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-01 |
| Decision Date | 1995-04-24 |