The following data is part of a premarket notification filed by Worthington Diagnostic Systems with the FDA for Flozyme* Uric Acid Reagent.
| Device ID | K790486 |
| 510k Number | K790486 |
| Device Name: | FLOZYME* URIC ACID REAGENT |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | WORTHINGTON DIAGNOSTIC SYSTEMS 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 | 1979-03-12 |
| Decision Date | 1979-04-23 |