The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Cholesterol Reagent Set.
| Device ID | K893479 |
| 510k Number | K893479 |
| Device Name: | CHOLESTEROL REAGENT SET |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Contact | Jennifer Line |
| Correspondent | Jennifer Line AMERICAN MONITOR CORP. P.O. BOX 68505 Indianapolis, IN 46268 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-04 |
| Decision Date | 1989-06-19 |