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 |