Urine Reagents STRIPS-8 Parameters (Modification)
FDA 510(k) K954977 · Teco Diagnostics
510(k) numberK954977
Submission
- Device name
- Urine Reagents STRIPS-8 Parameters (Modification)
- Applicant
- Teco Diagnostics
Placentia, CA, US - Received
- October 16, 1995
- Decision date
- March 11, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JRE – Refractometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2800
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941906 | Model 2730 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941903 | Model 2740 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941901 | Model 2721 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 01/17/1995SE |
| K941905 | Model 3461 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941904 | Model A300CL Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K941902 | Model 3471 Clinical RefractometerJRE · Traditional | Vee Gee Scientific, Inc. | 12/13/1994SE |
| K891681 | Dilectron Urinary Conductivity ProbeJRE · Traditional | Gyrus Medical , Ltd. | 05/01/1990SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | Kyoto Diagnostics, Inc. | 07/16/1984SE |
| K831213 | Specific Gravity InstrumentJRE · Traditional | Iris | 06/30/1983SE |
| K811342 | Reagent Strips for UrinalysisJRE · Traditional | Miles Laboratories, Inc. | 09/01/1981SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170118 | Scanostics UTI Check Application Test SystemJMT · Traditional | 09/21/2017SE |
| K161527 | Teco Creatinine Enzymatic Reagent KitJFY · Traditional | 07/21/2017SE |
| K170200 | Carbon Dioxide Reagent SetKHS · Traditional | 06/01/2017SE |
| K160372 | Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional | 07/22/2016SE |
| K152835 | Uritek TC-201 Urine Chemistry Test SystemJFY · Traditional | 03/07/2016SE |
| K141289 | Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional | 07/24/2015SE |
| K131600 | URS-2GP (Glucose Protein) Urine StripsJIL · Traditional | 05/29/2014SE |
| K111206 | Teco Diagnostics Saliva Alcohol TestDIC · Traditional | 10/04/2011SE |
| K100024 | Teco Diagnostics Uti Detection StripsJMT · Traditional | 02/17/2011SE |
| K101673 | Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, URS-10JIL · Traditional | 02/04/2011SE |
Questions and answers
When was Urine Reagents STRIPS-8 Parameters (Modification) cleared by the FDA?
Urine Reagents STRIPS-8 Parameters (Modification) (K954977) received a 510(k) decision of Substantially Equivalent on March 11, 1996, 147 days after the submission was received.
What is the product code of K954977?
The FDA product code is JRE – Refractometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2800.