Sandare Uric Acid Procedure
FDA 510(k) K812313 · Sandare Chemical Co., Inc.
510(k) numberK812313
Submission
- Device name
- Sandare Uric Acid Procedure
- Applicant
- Sandare Chemical Co., Inc.
Mchenry, IL, US - Received
- August 17, 1981
- Decision date
- September 1, 1981
- 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 |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | Livonia Diagnostics, Inc. | 10/30/1984SE |
| K811764 | Uric Acid Reagent SetLFQ · Traditional | Anco Medical Reagents & Assoc. | 08/20/1981SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K872852 | Eagle Diagnostics Glycohemoglobin Unitized TestLCP · Traditional | 09/29/1987SE |
| K862556 | Sandare Glycohemoglobin ProcedureLCP · Traditional | 08/08/1986SE |
| K860684 | Sandare BCG Albumin ProcedureCIX · Traditional | 03/17/1986SE |
| K851395 | Sandare Iron-Binding Capacity ProcedureJMO · Traditional | 05/07/1985SE |
| K851394 | Sandare Iron ProcedureJIY · Traditional | 04/30/1985SE |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | 12/10/1984SE |
| K842516 | Sandare Acid Phosphatase ProcedureCJR · Traditional | 08/17/1984SE |
| K833898 | Tri-Level Bilirubin ControlsJJX · Traditional | 01/13/1984SE |
| K832942 | Total & Direct Bilirubin ProceduresCIG · Traditional | 11/07/1983SE |
| K832632 | Albumin Procedure BCPCJW · Traditional | 09/12/1983SE |
Questions and answers
When was Sandare Uric Acid Procedure cleared by the FDA?
Sandare Uric Acid Procedure (K812313) received a 510(k) decision of Substantially Equivalent on September 1, 1981, 15 days after the submission was received.
What is the product code of K812313?
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.