The following data is part of a premarket notification filed by Randox Laboratories Ltd with the FDA for Direct Hdl Cholesterol (hdl).
| Device ID | K153435 |
| 510k Number | K153435 |
| Device Name: | Direct HDL Cholesterol (HDL) |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | Randox Laboratories Ltd 55 Diamond Road Ardmore Crumlin, GB Bt29 4qy |
| Contact | Pauline Armstrong |
| Correspondent | Pauline Armstrong Randox Laboratories Ltd 55 Diamond Road Ardmore Crumlin, GB Bt29 4qy |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596204 | K153435 | 000 |