The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Magnetic Hdl Cholesterol Test.
| Device ID | K944975 |
| 510k Number | K944975 |
| Device Name: | MAGNETIC HDL CHOLESTEROL TEST |
| Classification | Ldl & Vldl Precipitation, Hdl |
| Applicant | REFERENCE DIAGNOSTICS, INC. 23 CROSBY DR. Bedford, MA 01730 |
| Contact | Joseph Lawlor |
| Correspondent | Joseph Lawlor REFERENCE DIAGNOSTICS, INC. 23 CROSBY DR. Bedford, MA 01730 |
| Product Code | LBR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-11 |
| Decision Date | 1995-08-02 |