The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Specialty Diluent.
| Device ID | K962235 |
| 510k Number | K962235 |
| Device Name: | VITROS SPECIALTY DILUENT |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Bradford M Spring |
| Correspondent | Bradford M Spring JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-11 |
| Decision Date | 1996-06-26 |