The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Hdl Cholesterol Control.
| Device ID | K904872 |
| 510k Number | K904872 |
| Device Name: | HDL CHOLESTEROL CONTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-30 |
| Decision Date | 1990-12-07 |