Dade, Baxter Travenol Diagnostics, Inc.
Medical device manufacturer in Mchenry, IL.
44510(k) clearances
0PMA approvals
0recalls
Device types
- JJT Enzyme Controls (Assayed And Unassayed) 4
- JPK Mixture, Hematology Quality Control 3
- JPA System, Multipurpose For In Vitro… 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- KHQ Radioassay, Triiodothyronine Uptake 2
- GJW Pipette, Pasteur 2
- JJS Controls For Blood-Gases, (Assayed And… 1
- GGM Control, Hemoglobin 1
- JBQ Antithrombin Iii Quantitation 1
- JQW Station, Pipetting And Diluting, For… 1
- KSO Centrifuge, Blood-Bank For In Vitro… 1
- JOZ System, Automated Platelet Aggregation 1
- GJP Control, Platelet 1
- GGN Plasma, Coagulation Control 1
- GFO Activated Partial Thromboplastin 1
- JGY Colorimetric Method, Triglycerides 1
- KSF Kit, Quality Control For Blood Banking… 1
- KSS Supplies, Blood-Bank 1
- CDX Radioimmunoassay, Total Thyroxine 1
- GJG Pipette, Quantitative, Hematology 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K800296 | Whole Blood Gas Control, Levels 1,2,&3GGM · Traditional | 03/05/1980SE |
| K792606 | Whole Blood Platelet Control Normal,JPK · Traditional | 02/13/1980SE |
| K792723 | Blood Fluid FiltersJKA · Traditional | 01/21/1980SE |
| K792607 | T3 Uptake (T3U) ReagentsKHQ · Traditional | 01/16/1980SE |
| K792443 | TSH RadioimmunoassayJLW · Traditional | 12/27/1979SE |
| K792442 | Ferritin RadioimmunoassayDBF · Traditional | 12/18/1979SE |
| K791922 | Harleco Brand Clinicard Lipase Test SetCET · Traditional | 11/27/1979SE |
| K792183 | Dade High Density Lipoprotein CholesteroLBS · Traditional | 11/13/1979SE |
| K790776 | Dade Low Ionic Strength Soluition (Liss)KSG · Traditional | 05/23/1979SE |
| K790767 | Immu-Tek Automatic CentrifugeKSN · Traditional | 05/23/1979SE |
| K790571 | Quik-StainIAF · Traditional | 04/23/1979SE |
| K790264 | Data-Tope Tri-Rac Radioassay ControlJJY · Traditional | 03/21/1979SE |
| K790204 | Plasma, Standardized NormalJPA · Traditional | 03/12/1979SE |
| K782150 | Flurometer, DadeJZT · Traditional | 02/15/1979SE |
| K781479 | Heparin AssayKFF · Traditional | 02/15/1979SE |
| K782098 | Reagent, Lysing and HemoglobinGGK · Traditional | 01/17/1979SE |
| K781478 | Plasminogen AssayDDX · Traditional | 11/15/1978SE |
| K781480 | Antithrombin III AssayJBQ · Traditional | 11/08/1978SE |
| K781593 | Ria ControlsJJY · Traditional | 10/17/1978SE |
| K781077 | Control, Hematology, CH-60JPK · Traditional | 07/27/1978SE |
| K780801 | Isozyme - Id CPK MarkerJJT · Traditional | 06/13/1978SE |
| K780208 | Aspirator, ManuelJQW · Traditional | 03/03/1978SE |
| K780281 | Immufuge Disp. LinerKSO · Traditional | 03/02/1978SE |
| K780047 | Platelet Aggregating ReagentsJOZ · Traditional | 03/02/1978SE |
| K771740 | Cardiozyme Ck-Control Level 1JJT · Traditional | 10/19/1977SE |
| K770974 | Cardiozyme Ck-Mb Reagents · Traditional | 08/26/1977SE |
| K771588 | Platelet Controls Normal & AbnormalGJP · Traditional | 08/25/1977SE |
| K771346 | Ci-Trol Coagulation Controls II & IIIGGN · Traditional | 08/22/1977SE |
| K771138 | Pipets Borosilicate GlassGJW · Traditional | 08/04/1977SE |
| K771137 | Pipets Uniform Drop Size BorosilicateGJW · Traditional | 08/04/1977SE |
| K770973 | Cardiozyme CK Control NormalJJT · Traditional | 08/04/1977SE |
| K770971 | Cardiozyme Ck-Control AbnormalJJT · Traditional | 08/04/1977SE |
| K770950 | Whole Blood Gas ControlJJS · Traditional | 08/02/1977SE |
| K770972 | Cardiozyme Ck-Total Reagents · Traditional | 07/15/1977SE |
| K761283 | Tri-Con Triglyceridge ReagentsJGY · Traditional | 02/24/1977SE |
| K761281 | Data-Tope T3 Uptake ProcedureKHQ · Traditional | 02/09/1977SE |
| K761284 | Unival Control CellsKSF · Traditional | 01/25/1977SE |
| K761303 | Immu-Sal Immunohematological SalineKSS · Traditional | 12/30/1976SE |
| K761282 | Data-Tope T4 Ria ProcedureCDX · Traditional | 12/30/1976SE |
| K760594 | Auto-Fi Coagulation InstrumentJPA · Traditional | 11/24/1976SE |
| K760719 | Uniform Drop Size Pasteur Type PipetsGJG · Traditional | 10/29/1976SE |
| K760549 | Platelet Controls, Normal & AbnormalJPK · Traditional | 10/08/1976SE |
| K760416 | Data-Tope System Digoxin RiaDOG · Traditional | 08/23/1976SE |
| K760318 | Actin, Activated Cephaloplastin ReagentGFO · Traditional | 08/03/1976SE |