Kyoto Diagnostics, Inc.
Medical device manufacturer in Elkhart, IN.
11510(k) clearances
0PMA approvals
0recalls
Device types
- JIL Method, Enzymatic, Glucose (Urinary… 4
- KQO Automated Urinalysis System 1
- CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) 1
- JMT Diazo (Colorimetric), Nitrite (Urinary… 1
- JIN Nitroprusside, Ketones (Urinary, Non-Quant.) 1
- JRE Refractometer For Clinical Use 1
- JJM Osmometer For Clinical Use 1
- CGA Glucose Oxidase, Glucose 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K861733 | Additional Kyotest Urine Test Reagent StripsJIL · Traditional | 07/25/1986SE |
| K843003 | Glucose Auto& Stat GA-1120CGA · Traditional | 09/28/1984SE |
| K842750 | Osmotic Pressure Auto & Stat OM-6010JJM · Traditional | 08/17/1984SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | 07/16/1984SE |
| K841715 | Kyotest UK Urine Test Reagent StripJIN · Traditional | 05/31/1984SE |
| K841714 | Kyotest 2V, Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K841713 | Kyotest Ug Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K840828 | Kyotest 8VJMT · Traditional | 05/14/1984SE |
| K840827 | Kyotest 5VCEN · Traditional | 05/14/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | 05/01/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | 04/19/1984SE |