The following data is part of a premarket notification filed by Simmler, Inc. with the FDA for Linear Enzymatic Uric Acid System.
| Device ID | K843938 |
| 510k Number | K843938 |
| Device Name: | LINEAR ENZYMATIC URIC ACID SYSTEM |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Contact | Craig H Reason |
| Correspondent | Craig H Reason SIMMLER, INC. 3755 FOREST PARK AVE. St. Louis, MO 63108 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-09 |
| Decision Date | 1984-10-30 |