The following data is part of a premarket notification filed by Wako Intl., Inc. with the FDA for Urea Nitrogen Test.
| Device ID | K781899 |
| 510k Number | K781899 |
| Device Name: | UREA NITROGEN TEST |
| Classification | Berthelot Indophenol, Urea Nitrogen |
| Applicant | WAKO INTL., INC. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | CDL |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-13 |
| Decision Date | 1978-12-20 |