The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Dt Ldl Cholesterol Kit.
| Device ID | K955904 |
| 510k Number | K955904 |
| Device Name: | EKTACHEM DT LDL CHOLESTEROL KIT |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Charles C Morganson, Jr. |
| Correspondent | Charles C Morganson, Jr. JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-29 |
| Decision Date | 1996-05-24 |