The following data is part of a premarket notification filed by Premd, Inc. with the FDA for Prevu Point Of Care Skin Sterol Test.
| Device ID | K062092 |
| 510k Number | K062092 |
| Device Name: | PREVU POINT OF CARE SKIN STEROL TEST |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | PREMD, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Contact | Thomas M Tsakeris |
| Correspondent | Thomas M Tsakeris PREMD, INC. 16809 BRIARDALE ROAD Rockville, MD 20855 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-09-15 |
| Summary: | summary |