The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Uric Acid Reagent Set.
| Device ID | K811764 |
| 510k Number | K811764 |
| Device Name: | URIC ACID REAGENT SET |
| Classification | Acid, Uric, Acid Reduction Of Ferric Ion |
| Applicant | ANCO MEDICAL REAGENTS & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LFQ |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-22 |
| Decision Date | 1981-08-20 |