The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Ly-pro-trol #acs-lp101.
| Device ID | K791825 |
| 510k Number | K791825 |
| Device Name: | LY-PRO-TROL #ACS-LP101 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-17 |
| Decision Date | 1979-10-01 |