The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Diagnostics Infinity Bun Reagent Kit.
| Device ID | K982236 |
| 510k Number | K982236 |
| Device Name: | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT |
| Classification | Urease And Glutamic Dehydrogenase, Urea Nitrogen |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | CDQ |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-25 |
| Decision Date | 1998-08-05 |
| Summary: | summary |