Uric Acid Reagent Set
FDA 510(k) K844075 · Livonia Diagnostics, Inc.
510(k) numberK844075
Submission
- Device name
- Uric Acid Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Livonia, MI, US - Received
- October 19, 1984
- Decision date
- October 30, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFQ – Acid, Uric, Acid Reduction Of Ferric Ion
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1775
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860111 | Uric Acid Reagent SetLFQ · Traditional | Technostics Intl. | 02/19/1986SE |
| K860142 | Uric Acid Reagent Set (Colorimetric)LFQ · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K812313 | Sandare Uric Acid ProcedureLFQ · Traditional | Sandare Chemical Co., Inc. | 09/01/1981SE |
| K811764 | Uric Acid Reagent SetLFQ · Traditional | Anco Medical Reagents & Assoc. | 08/20/1981SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844283 | SGPT Reagent SetCKD · Traditional | 11/27/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | 11/20/1984SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | 11/13/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | 10/30/1984SE |
Questions and answers
When was Uric Acid Reagent Set cleared by the FDA?
Uric Acid Reagent Set (K844075) received a 510(k) decision of Substantially Equivalent on October 30, 1984, 11 days after the submission was received.
What is the product code of K844075?
The FDA product code is LFQ – Acid, Uric, Acid Reduction Of Ferric Ion, a Class I (low risk) device regulated under 21 CFR 862.1775.