Uropaper Eiken GK
FDA 510(k) K932363 · Tanabe U.S.A., Inc.
510(k) numberK932363
Submission
- Device name
- Uropaper Eiken GK
- Applicant
- Tanabe U.S.A., Inc.
San Diego, CA, US - Received
- April 19, 1993
- Decision date
- November 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K932368 | Uropaper Eiken 6BJIL · Traditional | 01/13/1994SE |
| K932366 | Uropaper Eiken HagJIL · Traditional | 11/26/1993SE |
| K932365 | Uropaper Eiken AGJIL · Traditional | 11/26/1993SE |
| K932369 | Uropaper Eiken 7JIL · Traditional | 11/16/1993SE |
| K932367 | Uropaper Eiken 8JIL · Traditional | 11/16/1993SE |
| K932364 | Uropaper Eiken GPJIL · Traditional | 11/16/1993SE |
| K931897 | UropaperJIL · Traditional | 11/16/1993SE |
Questions and answers
When was Uropaper Eiken GK cleared by the FDA?
Uropaper Eiken GK (K932363) received a 510(k) decision of Substantially Equivalent on November 16, 1993, 211 days after the submission was received.
What is the product code of K932363?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.