Kyotest 2V, Urine Test Reagent Strip
FDA 510(k) K841714 · Kyoto Diagnostics, Inc.
510(k) numberK841714
Submission
- Device name
- Kyotest 2V, Urine Test Reagent Strip
- Applicant
- Kyoto Diagnostics, Inc.
Mchenry, IL, US - Received
- April 24, 1984
- Decision date
- May 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1340
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis SystemJIL · Traditional | Arkray, Inc. | 04/13/2023SE |
| K183432 | cobas u 601 urinalysis test systemJIL · Traditional | Roche Diagnostics | 05/07/2019SE |
| K173327 | DIP/U.S. Urine Analysis Test SystemJIL · Traditional | Healthy.Io, Ltd. | 07/18/2018SE |
| K180356 | inui In-Home Urine Analysis Test SystemJIL · Traditional | Scanadu, Inc. | 05/25/2018SE |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional | DFI Co., Ltd. | 05/23/2018SE |
| K171521 | DUS R-50S (Urine Chemistry system)JIL · Traditional | DFI Co., Ltd. | 02/16/2018SE |
| K171083 | iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional | Iris Diagnostics, A Division of Iris… | 05/12/2017SE |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional | Arkray, Inc. | 10/07/2016SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | Teco Diagnostics, Inc. | 07/22/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | Teco Diagnostics | 07/24/2015SE |
More from Teco Diagnostics
| 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 |
| 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 |
Questions and answers
When was Kyotest 2V, Urine Test Reagent Strip cleared by the FDA?
Kyotest 2V, Urine Test Reagent Strip (K841714) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 37 days after the submission was received.
What is the product code of K841714?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.