Uric Acid
FDA 510(k) K850933 · Dilab, Inc.
510(k) numberK850933
Submission
- Device name
- Uric Acid
- Applicant
- Dilab, Inc.
Miami, FL, US - Received
- March 7, 1985
- Decision date
- June 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDH – Acid, Uric, Phosphotungstate Reduction
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K841067 | Uric Acid Reagent SetCDH · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K813076 | Phosphotungstate Reduction, Uric AcidCDH · Traditional | American Monitor Corp. | 11/16/1981SE |
| K810088 | Uric Acid (TPTZ) ColorinmetricCDH · Traditional | Bio-Analytics Laboratories, Inc. | 01/28/1981SE |
| K800672 | Smac Replacement Reagents/Determ-Uric-AcCDH · Traditional | Diagnostic Solutions, Inc. | 05/28/1980SE |
| K800190 | Stanbio Direct Uric Acid Test Set #0770CDH · Traditional | Stanbio Laboratory | 02/13/1980SE |
| K792412 | Elvi Uric AcidCDH · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K792403 | Elvi Uric Acid-Colorimetric MethodCDH · Traditional | Volu Sol Medical Industries | 12/07/1979SE |
| K790019 | Serum, Uric Acid DeterminationCDH · Traditional | Fisher Scientific Co., LLC | 02/26/1979SE |
| K772082 | Enzac Uric Acid 100-TEST KitCDH · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/28/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K862530 | Rapid AS LatexGTQ · Traditional | 04/21/1987SE |
| K850931 | AlbuminCIX · Traditional | 06/26/1985SE |
| K850938 | CholesterolCGO · Traditional | 06/25/1985SE |
| K850936 | Total ProteinsCEK · Traditional | 06/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | 06/25/1985SE |
| K850932 | CreatinineCGX · Traditional | 06/25/1985SE |
| K850937 | UreaCDW · Traditional | 06/10/1985SE |
| K850935 | ChlorideCHJ · Traditional | 06/10/1985SE |
| K850930 | GlucoseCGE · Traditional | 06/10/1985SE |
| K850929 | CalciumCIC · Traditional | 06/10/1985SE |
Questions and answers
When was Uric Acid cleared by the FDA?
Uric Acid (K850933) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 110 days after the submission was received.
What is the product code of K850933?
The FDA product code is CDH – Acid, Uric, Phosphotungstate Reduction, a Class I (low risk) device regulated under 21 CFR 862.1775.