The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem Hdl-cholesterol Reagent.
Device ID | K830207 |
510k Number | K830207 |
Device Name: | RAICHEM HDL-CHOLESTEROL REAGENT |
Classification | Ldl & Vldl Precipitation, Hdl |
Applicant | REAGENTS APPLICATIONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LBR |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-21 |
Decision Date | 1983-03-21 |