Elvi Uric Acid-Colorimetric Method
FDA 510(k) K792403 · Volu Sol Medical Industries
510(k) numberK792403
Submission
- Device name
- Elvi Uric Acid-Colorimetric Method
- Applicant
- Volu Sol Medical Industries
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 7, 1979
- 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 |
|---|---|---|---|
| K850933 | Uric AcidCDH · Traditional | Dilab, Inc. | 06/25/1985SE |
| 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 |
| 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 |
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| K822126 | Volu-Sol Carnoy FluidIGM · Traditional | 08/05/1982SE |
| K822038 | Volu-Sol Orange G-6(GILLS-MODHZH · Traditional | 08/03/1982SE |
| K822037 | Volu-Sol Tap Water SubstitutePPM · Traditional | 08/03/1982SE |
| K822036 | Volu-Sol DecalciferKDX · Traditional | 08/03/1982SE |
| K822035 | Volu-Sol Gills EaHZJ · Traditional | 08/03/1982SE |
| K812906 | Elvi Biclot 816KQG · Traditional | 07/22/1982SE |
| K821541 | Hematoxylin IIIHYJ · Traditional | 06/10/1982SE |
Questions and answers
When was Elvi Uric Acid-Colorimetric Method cleared by the FDA?
Elvi Uric Acid-Colorimetric Method (K792403) received a 510(k) decision of Substantially Equivalent on December 7, 1979, 11 days after the submission was received.
What is the product code of K792403?
The FDA product code is CDH – Acid, Uric, Phosphotungstate Reduction, a Class I (low risk) device regulated under 21 CFR 862.1775.