The following data is part of a premarket notification filed by Harleco with the FDA for Ultrachem Uric Acid Aldh, Item #65047.
| Device ID | K812500 |
| 510k Number | K812500 |
| Device Name: | ULTRACHEM URIC ACID ALDH, ITEM #65047 |
| Classification | Acid, Uric, Uricase (u.v.) |
| Applicant | HARLECO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CDO |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-31 |
| Decision Date | 1981-09-23 |