Kyotest 5V
FDA 510(k) K840827 · Kyoto Diagnostics, Inc.
510(k) numberK840827
Submission
- Device name
- Kyotest 5V
- Applicant
- Kyoto Diagnostics, Inc.
Walker, MI, US - Received
- February 24, 1984
- Decision date
- May 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| 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 |
| K030650 | Stoneguard II Reagent Strips for Urinalysis and Confirm Control SolutionsCEN · Traditional | Uridynamics, Inc. | 04/14/2003SE |
| K962718 | Femexam TestcardCEN · Traditional | Litmus Concepts, Inc. | 02/07/1997SE |
| 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 |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K861733 | Additional Kyotest Urine Test Reagent StripsJIL · Traditional | 07/25/1986SE |
| K843003 | Glucose Auto& Stat GA-1120CGA · Traditional | 09/28/1984SE |
| K842750 | Osmotic Pressure Auto & Stat OM-6010JJM · Traditional | 08/17/1984SE |
| K842168 | Atago Urine Specific Gravity & SerumJRE · Traditional | 07/16/1984SE |
| K841715 | Kyotest UK Urine Test Reagent StripJIN · Traditional | 05/31/1984SE |
| K841714 | Kyotest 2V, Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K841713 | Kyotest Ug Urine Test Reagent StripJIL · Traditional | 05/31/1984SE |
| K840828 | Kyotest 8VJMT · Traditional | 05/14/1984SE |
| K840996 | Urine Analyzer SystemKQO · Traditional | 05/01/1984SE |
| K840829 | Kyotest UgkJIL · Traditional | 04/19/1984SE |
Questions and answers
When was Kyotest 5V cleared by the FDA?
Kyotest 5V (K840827) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 80 days after the submission was received.
What is the product code of K840827?
The FDA product code is CEN – Dye-Indicator, Ph (Urinary, Non-Quantitative), a Class I (low risk) device regulated under 21 CFR 862.1550.