The following data is part of a premarket notification filed by Laboratory Corporation Of America Holdings with the FDA for Extended Lipid Panel Assay.
| Device ID | K181373 |
| 510k Number | K181373 |
| Device Name: | Extended Lipid Panel Assay |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | Laboratory Corporation Of America Holdings 500 Perimeter Park Drive Morrisville, NC 27560 |
| Contact | Suzette Warner |
| Correspondent | Suzette Warner Laboratory Corporation Of America Holdings 500 Perimeter Park Drive Morrisville, NC 27560 |
| Product Code | CHH |
| Subsequent Product Code | CDT |
| Subsequent Product Code | LBS |
| Subsequent Product Code | MSJ |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-24 |
| Decision Date | 2018-10-18 |
| Summary: | summary |