Uric Acid Reagent Set (Colorimetric)
FDA 510(k) K860142 · Sterling Diagnostics, Inc.
510(k) numberK860142
Submission
- Device name
- Uric Acid Reagent Set (Colorimetric)
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- January 14, 1986
- Decision date
- February 11, 1986
- 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 |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | Livonia Diagnostics, Inc. | 10/30/1984SE |
| 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 |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Uric Acid Reagent Set (Colorimetric) cleared by the FDA?
Uric Acid Reagent Set (Colorimetric) (K860142) received a 510(k) decision of Substantially Equivalent on February 11, 1986, 28 days after the submission was received.
What is the product code of K860142?
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.