The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Clinical Chemistry Urea Nitrogen/urea (bun/urea).
| Device ID | K961196 |
| 510k Number | K961196 |
| Device Name: | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) |
| Classification | Urease, Photometric, Urea Nitrogen |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Charles C Morganson |
| Correspondent | Charles C Morganson JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | CDN |
| CFR Regulation Number | 862.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-27 |
| Decision Date | 1996-05-15 |