The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Ektachem Clinical Chemistry Slide Potassium (k+).
| Device ID | K961115 |
| 510k Number | K961115 |
| Device Name: | EKTACHEM CLINICAL CHEMISTRY SLIDE POTASSIUM (K+) |
| Classification | Electrode, Ion Specific, Potassium |
| 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 | CEM |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-20 |
| Decision Date | 1996-05-07 |