The following data is part of a premarket notification filed by Micro-bio-logics with the FDA for Indi Kwik (tm) Co/two Kit.
| Device ID | K855198 |
| 510k Number | K855198 |
| Device Name: | INDI KWIK (TM) CO/TWO KIT |
| Classification | Kit, Quality Control For Culture Media |
| 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 | JTR |
| CFR Regulation Number | 866.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-27 |
| Decision Date | 1986-01-14 |