The following data is part of a premarket notification filed by Carolina Liquid Chemistries Corp. with the FDA for Carolina Liquid Chemistries Hdl Cholesterol Reagent.
Device ID | K132711 |
510k Number | K132711 |
Device Name: | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT |
Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
Applicant | CAROLINA LIQUID CHEMISTRIES CORP. 575 N. PATTERSON AVE. SUITE 430 Winston-salem, NC 27101 |
Contact | Philip G Shugart |
Correspondent | Philip G Shugart CAROLINA LIQUID CHEMISTRIES CORP. 575 N. PATTERSON AVE. SUITE 430 Winston-salem, NC 27101 |
Product Code | LBS |
CFR Regulation Number | 862.1475 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-29 |
Decision Date | 2014-05-08 |
Summary: | summary |