The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Rdi Lipidirect Magnetic Ldl Reagent.
| Device ID | K964064 |
| 510k Number | K964064 |
| Device Name: | RDI LIPIDIRECT MAGNETIC LDL REAGENT |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | REFERENCE DIAGNOSTICS, INC. 23 CROSBY DR. Bedford, MA 01730 |
| Contact | Joseph Lawlor, Ph.d. |
| Correspondent | Nancy Sauer RDD CONSULTANTS, INC. 401 SPRUCE ST. Louisville, CO 80027 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1996-10-10 |
| Decision Date | 1996-11-20 |