The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Hdl Cholesterol Reagent.
Device ID | K911406 |
510k Number | K911406 |
Device Name: | HDL CHOLESTEROL REAGENT |
Classification | Ldl & Vldl Precipitation, Hdl |
Applicant | GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
Contact | Russell H Herndon |
Correspondent | Russell H Herndon GENZYME CORP. ONE KENDALL SQUARE Cambridge, MA 02139 |
Product Code | LBR |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-29 |
Decision Date | 1991-05-22 |