Nuclear Diagnostics, Inc.
Medical device manufacturer in Stockholm, SE.
24510(k) clearances
0PMA approvals
0recalls
Device types
- CEE Radioimmunoassay, Thyroxine-Binding Globulin 3
- CDX Radioimmunoassay, Total Thyroxine 3
- KHQ Radioassay, Triiodothyronine Uptake 2
- CHI Lipase-Esterase, Enzymatic, Photometric… 2
- JLW Radioimmunoassay, Thyroid-Stimulating Hormone 2
- JQG Radiometric, Fe59, Iron Binding Capacity 1
- JFH Acid Phosphatase (Prostatic), Tartrate… 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CEC Radioimmunoassay, Free Thyroxine 1
- CET Olive Oil Emulsion (Turbidimetric), Lipase 1
- DNL Radioimmunoassay, Digoxin (125-I), Rabbit… 1
- IWE Monitor, Patient Position, Light-Beam 1
- CDP Radioimmunoassay, Total Triiodothyronine 1
- CGR Radioimmunoassay, Cortisol 1
- JNO N-Benzoyl-L-Arginine Ethyl Ester (U.V.)… 1
- LLZ System, Image Processing, Radiological 1
- KPS System, Tomography, Computed, Emission 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K021656 | Hermes Hdaq Acquisition Station and Hermes Workstation, Ver. 3.4KPS · Special | 06/13/2002SE |
| K002782 | Hermes HD Aq Acquisition Station and Hermes WorkstationLLZ · Traditional | 12/05/2000SE |
| K923917 | Elipase Human Pancreatic Lipase EnzymeimmunoassayCHI · Traditional | 02/25/1994SE |
| K932406 | NUCLITRYP(TM)(I125)-HUMAN Pancrea Cath Try Rad KitJNO · Traditional | 12/02/1993SE |
| K872177 | Tipsep-Cortisol Ria Diagnostic KitCGR · Traditional | 06/17/1987SE |
| K862312 | Enzlipase, Enzymatic Lipase KitCHI · Traditional | 09/26/1986SE |
| K860472 | Nuclear Laser Alignment System for Cardic StressIWE · Traditional | 07/03/1986SE |
| K861735 | Tipsep-Tbg AssayCEE · Traditional | 06/13/1986SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | 06/25/1985SE |
| K833713 | Serum Thyrotropin Assay Kit, Tipsep-JLW · Traditional | 12/29/1983SE |
| K823860 | Nuclipase (I125) Pancreatic LipaseCET · Traditional | 04/18/1983SE |
| K811558 | Tsh-P.E.G.JLW · Traditional | 06/18/1981SE |
| K810906 | Tri-Level Ndi ControlJJY · Traditional | 04/14/1981SE |
| K802886 | Nucli-Pap TM-(I125)-PAP Radioimmunoas-JFH · Traditional | 01/28/1981SE |
| K792599 | TIPSEP-T4(RIA) T4 RadioimmunoassayCDX · Traditional | 01/16/1980SE |
| K792484 | TIPSEP-T3U Triiodothyronine UptakeKHQ · Traditional | 12/27/1979SE |
| K790133 | SPINSEP-FE59JQG · Traditional | 03/02/1979SE |
| K781560 | Ria Diag. Test Kit for Indexing Thyrox.CEC · Traditional | 10/17/1978SE |
| K780644 | Radioassay for Total Serum ThyroxineCDX · Traditional | 04/28/1978SE |
| K780486 | STIKSEP-T3 KitCEE · Traditional | 04/28/1978SE |
| K780423 | STIKSEP-T4 Ria KitCDX · Traditional | 03/30/1978SE |
| K780292 | Tria-Peg Ria Diag. KitCDP · Traditional | 03/02/1978SE |
| K771854 | SPINSEP-T3KHQ · Traditional | 12/22/1977SE |
| K771341 | Spinsep-TbgCEE · Traditional | 08/10/1977SE |