Sgot Reagent Set
FDA 510(k) K821209 · Omega Medical Electronics
510(k) numberK821209
Submission
- Device name
- Sgot Reagent Set
- Applicant
- Omega Medical Electronics
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- July 14, 1982
- 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 |
| K844322 | Sgot Reagent SetCIQ · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| K841065 | Sgot Reagent SetCIQ · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K823691 | Phosphorus Reagent SetCEO · Traditional | 01/07/1983SE |
| K821212 | Urea Nitrogen Reagent SetCDW · Traditional | 07/22/1982SE |
| K821206 | Sgpt-Uv Reagent SetCKA · Traditional | 07/22/1982SE |
| K821204 | Glucose(Enzymatic) Reagent SetCGA · Traditional | 07/22/1982SE |
| K821208 | Sgot-Uv Reagent SetCIT · Traditional | 07/20/1982SE |
| K821205 | Triglyceride Reagent SetCDT · Traditional | 07/20/1982SE |
| K821201 | Ldh-Uv Reagent SetCFJ · Traditional | 07/20/1982SE |
| K821207 | SGPT Reagent SetCKD · Traditional | 07/14/1982SE |
| K821213 | Uric Acid Reagent SetCDH · Traditional | 07/13/1982SE |
| K821210 | Serum Total Protein Reagent SetCEK · Traditional | 07/13/1982SE |
Questions and answers
When was Sgot Reagent Set cleared by the FDA?
Sgot Reagent Set (K821209) received a 510(k) decision of Substantially Equivalent on July 14, 1982, 78 days after the submission was received.
What is the product code of K821209?
The FDA product code is CIQ – Diazo, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.