The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Infinity Uric Acid Reagent Kit.
| Device ID | K982251 |
| 510k Number | K982251 |
| Device Name: | SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT |
| Classification | Acid, Uric, Uricase (u.v.) |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | CDO |
| CFR Regulation Number | 862.1775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-26 |
| Decision Date | 1998-08-18 |
| Summary: | summary |