The following data is part of a premarket notification filed by Enzyme Technology, Inc. with the FDA for Uric Acid (uricase) Reagent, Universal.
| Device ID | K912028 |
| 510k Number | K912028 |
| Device Name: | URIC ACID (URICASE) REAGENT, UNIVERSAL |
| Classification | Acid, Uric, Uricase (colorimetric) |
| Applicant | ENZYME TECHNOLOGY, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Contact | Peter R Klamka |
| Correspondent | Peter R Klamka ENZYME TECHNOLOGY, INC. 415 HOWE AVE. Shelton, CT 06484 |
| Product Code | KNK |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-08 |
| Decision Date | 1991-12-18 |