The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Urea Nitrogen (bun) Liqui-uv.
| Device ID | K962418 |
| 510k Number | K962418 |
| Device Name: | UREA NITROGEN (BUN) LIQUI-UV |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | Kirk Johnson |
| Correspondent | Kirk Johnson STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-12-26 |
| Summary: | summary |