The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Miles Urine Urea Nitrogen Method.
| Device ID | K923035 |
| 510k Number | K923035 |
| Device Name: | MILES URINE UREA NITROGEN METHOD |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Robert L Habig |
| Correspondent | Robert L Habig HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | CDQ |
| 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 | 1992-09-09 |