Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions
FDA 510(k) K030650 · Uridynamics, Inc.
510(k) numberK030650
Submission
- Device name
- Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions
- Applicant
- Uridynamics, Inc.
Indianapolis, IN, US - Received
- February 28, 2003
- Decision date
- April 14, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091287 | Vs-Sense TestCEN · Traditional | Common Sense , Ltd. | 08/31/2009SE |
| K071100 | Amniscreen Home Detection Liner KitCEN · Traditional | Common Sense , Ltd. | 10/15/2007SE |
| K051727 | Aimstick Urine Reagent StripsCEN · Traditional | Germaine Laboratories, Inc. | 10/26/2005SE |
| K040008 | Quickvue Advance PH and Amines GLL TestCEN · Traditional | Quidel Corp. | 04/29/2004SE |
| K962718 | Femexam TestcardCEN · Traditional | Litmus Concepts, Inc. | 02/07/1997SE |
| K840827 | Kyotest 5VCEN · Traditional | Kyoto Diagnostics, Inc. | 05/14/1984SE |
| K830824 | Urine Screening KitCEN · Traditional | Syn-Kit, Inc. | 06/12/1983SE |
| K830979 | Helena Biostrip PHCEN · Traditional | Helena Laboratories | 05/05/1983SE |
| K830091 | Lith a Test TMCEN · Traditional | Lenal Creative Approaches, Inc. | 02/15/1983SE |
| K822241 | FOLATE/B12 Duo-Bead RadioassayCEN · Traditional | Abbott Laboratories | 10/26/1982SE |
Questions and answers
When was Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions cleared by the FDA?
Stoneguard II Reagent Strips for Urinalysis and Confirm Control Solutions (K030650) received a 510(k) decision of Substantially Equivalent on April 14, 2003, 45 days after the submission was received.
What is the product code of K030650?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.