The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Infinity Cholesterol Reagent (procedure No. 401).
| Device ID | K980667 |
| 510k Number | K980667 |
| Device Name: | INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| 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 | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-20 |
| Decision Date | 1998-04-21 |
| Summary: | summary |