The following data is part of a premarket notification filed by Connecticut Diagnostics, Ltd. with the FDA for Uric Acid Diagnostic Reagent.
| Device ID | K801898 |
| 510k Number | K801898 |
| Device Name: | URIC ACID DIAGNOSTIC REAGENT |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | CONNECTICUT DIAGNOSTICS, LTD. 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 | 1980-08-08 |
| Decision Date | 1980-10-10 |