Health Check Uri-Test Glucose in Urine Test
FDA 510(k) K954968 · Tcpi, Inc.
510(k) numberK954968
Submission
- Device name
- Health Check Uri-Test Glucose in Urine Test
- Applicant
- Tcpi, Inc.
Beverly, MA, US - Received
- October 27, 1995
- Decision date
- July 26, 1996
- 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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| 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 |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K980776 | One Step Urine Drug of Abuse: Benzodiazepine TestJXM · Traditional | 04/29/1998SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | 08/20/1996SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | 07/22/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | 08/17/1995SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
Questions and answers
When was Health Check Uri-Test Glucose in Urine Test cleared by the FDA?
Health Check Uri-Test Glucose in Urine Test (K954968) received a 510(k) decision of Substantially Equivalent on July 26, 1996, 273 days after the submission was received.
What is the product code of K954968?
The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.