The following data is part of a premarket notification filed by Rai, Inc. with the FDA for Cholesterol Reagent Enzymatic.
| Device ID | K803287 |
| 510k Number | K803287 |
| Device Name: | CHOLESTEROL REAGENT ENZYMATIC |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | RAI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-30 |
| Decision Date | 1981-01-16 |