Kyotest 8V
FDA 510(k) K840828 · Kyoto Diagnostics, Inc.
510(k) numberK840828
Submission
- Device name
- Kyotest 8V
- Applicant
- Kyoto Diagnostics, Inc.
Walker, MI, US - Received
- February 24, 1984
- Decision date
- May 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1510
- Specialty
- Clinical Chemistry
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| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 10/30/2025SE |
| K242767 | Safecare Urinary Tract Infection TestJMT · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 01/10/2025SE |
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | Teco Diagnostics | 09/21/2017SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | Teco Diagnostics | 02/17/2011SE |
| K993850 | Urinalysis Reagent Strips (10 Parameters)JMT · Traditional | International Newtech Development, Inc. | 01/03/2000SE |
| K990873 | Dbest Urinary Tract Infection Test Kit for Home-UseJMT · Traditional | Ameritek, Inc. | 09/01/1999SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | Tcpi, Inc. | 07/22/1996SE |
| K960888 | Chek-Stix U.T.I. Self-TestJMT · Traditional | Bayer Corp. | 07/05/1996SE |
| K953672 | First Choice Urinary Tract Infection Test StripsJMT · Traditional | Polymer Technology Intl. | 07/01/1996SE |
More from Polymer Technology Intl.
| 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 |
| K840827 | Kyotest 5VCEN · Traditional | 05/14/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | 05/01/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | 04/19/1984SE |
Questions and answers
When was Kyotest 8V cleared by the FDA?
Kyotest 8V (K840828) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 80 days after the submission was received.
What is the product code of K840828?
The FDA product code is JMT – Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), a Class I (low risk) device regulated under 21 CFR 862.1510.