Urisite Urine Collection Kit for Microalbumin/Creatinine Testing
FDA 510(k) K001810 · Flexsite Diagnostics, Inc.
510(k) numberK001810
Submission
- Device name
- Urisite Urine Collection Kit for Microalbumin/Creatinine Testing
- Applicant
- Flexsite Diagnostics, Inc.
Washington, DC, US - Received
- June 15, 2000
- Decision date
- August 14, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1645
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222921 | Minuteful-kidney testJIR · Traditional | Healthy.Io, Ltd. | 09/08/2023SE |
| K210069 | Minuteful - kidney testJIR · Traditional | Healthy.Io, Ltd. | 07/06/2022SE |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)JIR · Traditional | ACON Laboratories, Inc. | 04/30/2015SE |
| K061419 | Teco Microalbumin 2-1 Combo StripsJIR · Traditional | Teco Diagnostics | 01/26/2007SE |
| K022538 | Immunodip Urinary Albumin Screen Assay, Catalogue Number 790-25JIR · Special | Diagnostic Chemicals, Ltd. (Usa) | 08/23/2002SE |
| K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15JIR · Traditional | Diagnostic Chemicals , Ltd. | 02/01/2000SE |
| K992257 | New Multiples Reagent StripsJIR · Traditional | Bayer Corp. | 11/24/1999SE |
| K991315 | Microalbustix Reagent Strips (OTC)JIR · Traditional | Bayer Corp. | 11/12/1999SE |
| K983774 | UalbJIR · Traditional | Abbott Laboratories | 01/28/1999SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | Tcpi, Inc. | 10/07/1998SE |
More from Tcpi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971919 | Ezchek/Hba Blood Collection KitLCP · Traditional | 09/05/1997SE |
Questions and answers
When was Urisite Urine Collection Kit for Microalbumin/Creatinine Testing cleared by the FDA?
Urisite Urine Collection Kit for Microalbumin/Creatinine Testing (K001810) received a 510(k) decision of Substantially Equivalent on August 14, 2000, 60 days after the submission was received.
What is the product code of K001810?
The FDA product code is JIR – Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1645.