The following data is part of a premarket notification filed by Hans J. Brouwers & Assoc. with the FDA for Cholesterol Test System.
| Device ID | K850390 |
| 510k Number | K850390 |
| Device Name: | CHOLESTEROL TEST SYSTEM |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect, IL 60056 |
| Contact | Hans J Brouwers |
| Correspondent | Hans J Brouwers HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect, IL 60056 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-07-09 |