The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnositcs Products-free T3 Reagent Pack (gem.1020)/free T3 Calibrators (gem.c020).
| Device ID | K970016 |
| 510k Number | K970016 |
| Device Name: | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-01-30 |