The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Hdl Cholesterol (hdlx) Assay.
| Device ID | K100010 |
| 510k Number | K100010 |
| Device Name: | HDL CHOLESTEROL (HDLX) ASSAY |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD MAIL STOP E2 SE08 Brea, CA 92821 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-05-14 |
| Summary: | summary |