Sgot Reagent Set
FDA 510(k) K844322 · Livonia Diagnostics, Inc.
510(k) numberK844322
Submission
- Device name
- Sgot Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Livonia, MI, US - Received
- November 7, 1984
- Decision date
- November 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIQ – Diazo, Ast/Sgot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881173 | Aspartate Aminotransferase (Colorimetric Method)CIQ · Traditional | Tech-Co, Inc. | 06/07/1988SE |
| K860216 | Sgot (Ast) Reagent SetCIQ · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K855189 | Glutamic Oxaloacetic Transaminase Reagent SetCIQ · Traditional | Technostics Intl. | 01/14/1986SE |
| K841065 | Sgot Reagent SetCIQ · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821209 | Sgot Reagent SetCIQ · Traditional | Omega Medical Electronics | 07/14/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| 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 |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| 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 Sgot Reagent Set cleared by the FDA?
Sgot Reagent Set (K844322) received a 510(k) decision of Substantially Equivalent on November 27, 1984, 20 days after the submission was received.
What is the product code of K844322?
The FDA product code is CIQ – Diazo, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.