The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Urea Nitrogen Reagent.
| Device ID | K922969 |
| 510k Number | K922969 |
| Device Name: | KING DIAGNOSTICS UREA NITROGEN REAGENT |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Contact | Frances Loh |
| Correspondent | Frances Loh KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis, IN 46220 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-19 |
| Decision Date | 1992-10-13 |