The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (gem.1025) And T3 Uptake Calibrators (gem.c025).
| Device ID | K964308 |
| 510k Number | K964308 |
| Device Name: | VITROS IMMUNODIAGNOSTICS PRODUCTS T3 UPTAKE REAGENT PACK (GEM.1025) AND T3 UPTAKE CALIBRATORS (GEM.C025) |
| Classification | Radioassay, Triiodothyronine Uptake |
| 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 | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1996-11-27 |