The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Uric-acid Test Enzymatic Colorimetric.
| Device ID | K831864 |
| 510k Number | K831864 |
| Device Name: | URIC-ACID TEST ENZYMATIC COLORIMETRIC |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | STANBIO LABORATORY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-10 |
| Decision Date | 1983-07-22 |