The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Direct Uric Acid Test Set #0770.
| Device ID | K800190 |
| 510k Number | K800190 |
| Device Name: | STANBIO DIRECT URIC ACID TEST SET #0770 |
| Classification | Acid, Uric, Phosphotungstate Reduction |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDH |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-02-13 |