The following data is part of a premarket notification filed by Accutech, Llc. with the FDA for Cholestrak Hdl Cholesterol Home Test.
| Device ID | K072836 |
| 510k Number | K072836 |
| Device Name: | CHOLESTRAK HDL CHOLESTEROL HOME TEST |
| Classification | Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl |
| Applicant | ACCUTECH, LLC. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus ACCUTECH, LLC. 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Product Code | LBS |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-03 |
| Decision Date | 2007-12-27 |