The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Cholesterol (rate) Reagent.
| Device ID | K902098 |
| 510k Number | K902098 |
| Device Name: | CHOLESTEROL (RATE) REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | SIGMA CHEMICAL CO. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Mathew Madappally |
| Correspondent | Mathew Madappally SIGMA CHEMICAL CO. 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 | 1990-05-08 |
| Decision Date | 1990-08-09 |