The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Enzymatic Urea Nitrogen Determinat #2010.
| Device ID | K893128 |
| 510k Number | K893128 |
| Device Name: | STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 |
| Classification | Berthelot Indophenol, Urea Nitrogen |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | William J Campbell |
| Correspondent | William J Campbell STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | CDL |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-25 |
| Decision Date | 1989-07-25 |