The following data is part of a premarket notification filed by Livonia Diagnostics, Inc. with the FDA for Glucose Oxidase Enzymatic Reagent Set.
| Device ID | K843528 |
| 510k Number | K843528 |
| Device Name: | GLUCOSE OXIDASE ENZYMATIC REAGENT SET |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIVONIA DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-07 |
| Decision Date | 1984-09-28 |