The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Uric Acid Reagent-enzymatic-color-520 Nm.
| Device ID | K812641 |
| 510k Number | K812641 |
| Device Name: | URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | REAGENTS APPLICATIONS, INC. 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 | 1981-09-16 |
| Decision Date | 1981-10-02 |