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 |