Johnson & Johnson Clinical Diagnostics, Inc.
Medical device manufacturer in Rochester, NY.
33510(k) clearances
0PMA approvals
0recalls
Device types
- JJY Multi-Analyte Controls, All Kinds (Assayed) 3
- CGJ Radioimmunoassay, Follicle-Stimulating… 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- DHA System, Test, Human Chorionic Gonadotropin 2
- CDP Radioimmunoassay, Total Triiodothyronine 2
- KLT Enzyme Immunoassay, Carbamazepine 1
- DBF Ferritin, Antigen, Antiserum, Control 1
- JGP Lowry (Colorimetric), Total Protein 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- KHO Fluorometer, For Clinical Use 1
- JJE Analyzer, Chemistry (Photometric… 1
- MRR System, Test, Low Density, Lipoprotein 1
- CGA Glucose Oxidase, Glucose 1
- CDN Urease, Photometric, Urea Nitrogen 1
- CJY Azo Dye, Calcium 1
- CEM Electrode, Ion Specific, Potassium 1
- JGS Electrode, Ion Specific, Sodium 1
- LDP Colorimetry, Acetaminophen 1
- DCK C-Reactive Protein, Antigen, Antiserum, And… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K980283 | Vitros Chemistry Products CRBM SlidesKLT · Traditional | 02/25/1998SE |
| K974644 | Vitros Immunodiagnostic Products Range VerifiersJJX · Traditional | 01/13/1998SE |
| K973517 | Vitros Immunodiagnostic Products Range VerifiersJJY · Traditional | 09/25/1997SE |
| K973030 | Vitros Immunodiagnostics Products/Ck-Mb Reagent PACK(GEM.1300)/CK-MB Calibrators…JJY · Traditional | 09/04/1997SE |
| K972133 | Vitros Immunodiagnostics Products Progesterone Reagent Pack (GEM.1070), Progesterone…JLS · Traditional | 06/24/1997SE |
| K970894 | Vitros Immunodiagnostics Products Total B-Hcg Reagent Pack (GEM.1075), Total B-Hcg…DHA · Traditional | 04/14/1997SE |
| K970643 | Vitros Immunodiagnostics Products Estradiol Reagent Pack(Gem. 1050)/ESTRADIOL…CHP · Traditional | 03/18/1997SE |
| K965142 | Vitros Immunodiagnostics Products Free T4 Reagent Pack (GEM.1015) Free T4 Calibrators…CEC · Traditional | 03/18/1997SE |
| K970281 | Vitros Immunodiagnostic Products Prolactin Reagent Pack/CalibratorsCFT · Traditional | 02/25/1997SE |
| K964982 | Vitros Immunodiagnostics Products LH Reagent Pack (GEM.1055) and LH Calibrators (GEM.CO55)CEP · Traditional | 02/20/1997SE |
| K964960 | Vitros Chemistry Products Upro SlidesJGP · Traditional | 02/18/1997SE |
| K964720 | Vitros Immunodiagnostics Products FSH Reagent Pack (Gem. 1005) FSH Calibrators (GEM.C005)CGJ · Traditional | 02/04/1997SE |
| K970016 | Vitros Immunodiagnositcs Products-Free T3 Reagent Pack (GEM.1020)/FREE T3 Calibrators…CDP · Traditional | 01/30/1997SE |
| K965048 | Vitros Immunoddiagnostics Products Re Controls (GEM.5015)JJY · Traditional | 01/27/1997SE |
| K964721 | Vitros Immunodiagnostics Products Total T4 Reagent Pack (GEM.1005) Total T4 Calibrators…KLI · Traditional | 12/18/1996SE |
| K964558 | Vitros Immunodiagnostics Products/Tsh Reagent Pack (Gem. 1001)/TSH CALIBRATORS(GEM.C001)JLW · Traditional | 12/16/1996SE |
| K964310 | Vitros Immunodiagnostics Product - Total T3 Reagent Pack (Gem .101) and Total…CDP · Traditional | 11/27/1996SE |
| K964308 | Vitros Immunodiagnostics Products T3 Uptake Reagent Pack (GEM.1025) and T3 Uptake…KHQ · Traditional | 11/27/1996SE |
| K962919 | Vitros Immunodiagnostic SystemKHO · Traditional | 10/18/1996SE |
| K962235 | Vitros Specialty DiluentJJE · Traditional | 06/26/1996SE |
| K955904 | Ektachem DT LDL Cholesterol KitMRR · Traditional | 05/24/1996SE |
| K955286 | Ektachem Clinical Chemistry Slide Glucose (Glu)CGA · Traditional | 05/17/1996SE |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)CDN · Traditional | 05/15/1996SE |
| K961226 | Ektachem Clinical Chemistry Calcium (Ca) SlideCJY · Traditional | 05/07/1996SE |
| K961115 | Ektachem Clinical Chemistry Slide Potassium (K+)CEM · Traditional | 05/07/1996SE |
| K961099 | Ektachem Clinical Chemistry Slide Sodium (Na+)JGS · Traditional | 05/07/1996SE |
| K954933 | Ektachem Clinical Chemistry Slide for AcetaminophenLDP · Traditional | 12/18/1995SE |
| K953197 | Ektachem Clinical Chemistry Slide C-Reactive Protein (CRP)DCK · Traditional | 07/31/1995SE |
| K952284 | Amerlite TBG AssayCEE · Traditional | 07/26/1995SE |
| K952283 | Amerlite HCG-60 AssayDHA · Traditional | 07/17/1995SE |
| K952211 | Amerlite TSH-30 Ultrasensitive Assay (LAN.0010Q/2010Q)JLW · Traditional | 07/14/1995SE |
| K952285 | Amerlite FSH AssayCGJ · Traditional | 07/03/1995SE |
| K952286 | Amerlite Ferritin II AssayDBF · Traditional | 06/20/1995SE |