The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Mif Procedure Kit.
| Device ID | K780346 |
| 510k Number | K780346 |
| Device Name: | MIF PROCEDURE KIT |
| Classification | Stains, Microbiologic |
| Applicant | MARION LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTS |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-01 |
| Decision Date | 1978-03-22 |