King Diagnostics, Inc.
Medical device manufacturer in Indianapolis, IN.
41510(k) clearances
0PMA approvals
0recalls
Device types
- JPA System, Multipurpose For In Vitro… 3
- CGA Glucose Oxidase, Glucose 2
- CFR Hexokinase, Glucose 2
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- JIS Calibrator, Primary 2
- KNK Acid, Uric, Uricase (Colorimetric) 2
- CHO Radioimmunoassay, Cyclic Amp 1
- CGO Lieberman-Burchard/Abell-Kendall… 1
- CIC Cresolphthalein Complexone, Calcium 1
- CEO Phosphomolybdate (Colorimetric), Inorganic… 1
- CIG Diazo Colorimetry, Bilirubin 1
- CEJ Tetraphenyl Borate, Colorimetry, Potassium 1
- CGE Orthotoluidine, Glucose 1
- GKR System, Hemoglobin, Automated 1
- JGZ O-Phthalaldehyde, Urea Nitrogen 1
- CFJ Nad Reduction/Nadh Oxidation, Lactate… 1
- JMO Ferrozine (Colorimetric) Iron Binding… 1
- CKE Acid Phosphatase, Thymolphthale… 1
- CEK Biuret (Colorimetric), Total Protein 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K933329 | King Diagnostics Iron and Total Iron Binding Capacity ReagentJMO · Traditional | 10/22/1993SE |
| K931834 | King Sodium/Potassium Standard ModifiedJIS · Traditional | 08/25/1993SE |
| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | 08/16/1993SE |
| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
| K922964 | King Diagnostic Triglycerides ReagentCDT · Traditional | 08/18/1992SE |
| K922835 | Calcium (Az III) ReagentCJY · Traditional | 08/04/1992SE |
| K922108 | King Diagnostics Ast (Got) ReagentCIT · Traditional | 07/15/1992SE |
| K922109 | King Diagnostics Alt (GPT) ReagentCKA · Traditional | 06/04/1992SE |
| K920809 | King Diagnostics Sodium/Potassium StandardJIS · Traditional | 04/17/1992SE |
| K912499 | King Diagnostics Cholesterol Reagent Strip TestCHH · Traditional | 09/27/1991SE |
| K912251 | King Diagnostics Glucose (HK) Reagent Strip TestCFR · Traditional | 07/18/1991SE |
| K884485 | KD Activated Partial Thromboplastin Time ReagentGFO · Traditional | 12/28/1988SE |
| K883640 | KD One-Stage Prothrombin Time TestJPA · Traditional | 10/31/1988SE |
| K883637 | KD 0.02 M Calcium Chloride SolutionJPA · Traditional | 10/31/1988SE |
| K883635 | KD 0.1 M Sodium Citrate SolutionJPA · Traditional | 10/31/1988SE |
| K882220 | Calibration KitJIW · Traditional | 08/02/1988SE |
| K873726 | Acid Phosphatase TestCKE · Traditional | 01/27/1988SE |
| K862498 | Alkaline Phosphatase TestCJE · Traditional | 09/26/1986SE |
| K862306 | King Diagnostics LDH TestCFJ · Traditional | 08/19/1986SE |
| K862208 | King Diagnostics Uric Acid TestKNK · Traditional | 07/08/1986SE |
| K831411 | Glucose Oxidase/Peroxidase TestCGA · Traditional | 07/06/1983SE |
| K820418 | K.D. Colorimetric Blood Urea N2 TestJGZ · Traditional | 03/11/1982SE |
| K812127 | King Diagnostics Hemoglobin TestGKR · Traditional | 08/25/1981SE |
| K811883 | King Diagnostics Glucose-O TestCGE · Traditional | 07/23/1981SE |
| K811882 | King Diagnostics Glucose TestCGA · Traditional | 07/23/1981SE |
| K811881 | King Diagnostics Total Bilirubin TestCIG · Traditional | 07/23/1981SE |
| K811749 | King Diagnostics Phosphorus TestCEO · Traditional | 07/10/1981SE |
| K811748 | King Diagnostics Calcium TestCIC · Traditional | 07/10/1981SE |
| K811747 | King Diagnostics Cholesterol TestCGO · Traditional | 07/10/1981SE |
| K811746 | King Diagnostics Cholesterol-Fe TestCHO · Traditional | 07/10/1981SE |
| K811687 | Uric Acid TestKNK · Traditional | 07/01/1981SE |
| K811673 | Total Protein TestCEK · Traditional | 06/25/1981SE |
| K811664 | Creatinine TestCGX · Traditional | 06/25/1981SE |
| K811662 | Albumin TestCIX · Traditional | 06/25/1981SE |
| K811661 | Potassium TestCEJ · Traditional | 06/25/1981SE |