The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Lyfo-kwik (tm) Coagulase Plasma.
| Device ID | K861312 |
| 510k Number | K861312 |
| Device Name: | LYFO-KWIK (TM) COAGULASE PLASMA |
| Classification | Plasma, Coagulase, Human, Horse And Rabbit |
| 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 | JTL |
| CFR Regulation Number | 866.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-08 |
| Decision Date | 1986-04-18 |