The following data is part of a premarket notification filed by Tech-neal Scientific, Inc. with the FDA for Urea Nitrogen (bun).
| Device ID | K880078 |
| 510k Number | K880078 |
| Device Name: | UREA NITROGEN (BUN) |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
| Contact | Arun Sanghavi |
| Correspondent | Arun Sanghavi TECH-NEAL SCIENTIFIC, INC. 817 OAKWOOD DR. Westmont, IL 60559 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-11 |
| Decision Date | 1988-02-11 |