The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostics Products Total T4 Reagent Pack (gem.1005) Total T4 Calibrators (gem.c005).
| Device ID | K964721 |
| 510k Number | K964721 |
| Device Name: | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 CALIBRATORS (GEM.C005) |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Contact | Ann M Quinn |
| Correspondent | Ann M Quinn JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-25 |
| Decision Date | 1996-12-18 |