The following data is part of a premarket notification filed by Helena Laboratories with the FDA for Lipotrol.
| Device ID | K792024 |
| 510k Number | K792024 |
| Device Name: | LIPOTROL |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | HELENA LABORATORIES 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 | 1979-10-09 |
| Decision Date | 1979-10-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LIPOTROL 74437283 1856524 Live/Registered |
ADVOCARE INTERNATIONAL, L.P. 1993-09-20 |