The following data is part of a premarket notification filed by Livonia Diagnostics, Inc. with the FDA for Sickle Cell Reagent Set.
| Device ID | K842368 |
| 510k Number | K842368 |
| Device Name: | SICKLE CELL REAGENT SET |
| Classification | Test, Sickle Cell |
| Applicant | LIVONIA DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GHM |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-15 |
| Decision Date | 1984-07-20 |