The following data is part of a premarket notification filed by Reference Diagnostics, Inc. with the FDA for Lipidirect Low Density Lipoprotein Cholesterol Tes.
| Device ID | K893740 |
| 510k Number | K893740 |
| Device Name: | LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | REFERENCE DIAGNOSTICS, INC. P.O. BOX 109 Arlington, MA 02174 |
| Contact | Lawlor, Phd. |
| Correspondent | Lawlor, Phd. REFERENCE DIAGNOSTICS, INC. P.O. BOX 109 Arlington, MA 02174 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-17 |
| Decision Date | 1990-03-19 |