The following data is part of a premarket notification filed by Livonia Diagnostics, Inc. with the FDA for Albumin Reagent Set.
| Device ID | K843831 |
| 510k Number | K843831 |
| Device Name: | ALBUMIN REAGENT SET |
| Classification | Bromcresol Green Dye-binding, Albumin |
| Applicant | LIVONIA DIAGNOSTICS, INC. 33091 WEST EIGHT MILE RD. Livonia, MI 48152 |
| Contact | Walter H Lambert |
| Correspondent | Walter H Lambert LIVONIA DIAGNOSTICS, INC. 33091 WEST EIGHT MILE RD. Livonia, MI 48152 |
| Product Code | CIX |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-01 |
| Decision Date | 1984-10-11 |