The following data is part of a premarket notification filed by Biorent Diagnostic, Inc. with the FDA for Colorimetric Uric Acid Reagent Set.
| Device ID | K820632 |
| 510k Number | K820632 |
| Device Name: | COLORIMETRIC URIC ACID REAGENT SET |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | BIORENT DIAGNOSTIC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-03-25 |