Glutamic Oxaloacetic Transaminase Reagent Set
FDA 510(k) K855189 · Technostics Intl.
510(k) numberK855189
Submission
- Device name
- Glutamic Oxaloacetic Transaminase Reagent Set
- Applicant
- Technostics Intl.
Washington, MI, US - Received
- December 26, 1985
- Decision date
- January 14, 1986
- 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 |
| K844322 | Sgot Reagent SetCIQ · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| 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 |
|---|---|---|
| K855188 | CPK (UV) Reagent KitJHS · Traditional | 03/05/1986SE |
| K860111 | Uric Acid Reagent SetLFQ · Traditional | 02/19/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | 02/18/1986SE |
| K860110 | Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent SetCKA · Traditional | 02/11/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 02/06/1986SE |
| K860112 | Total Lipids Reagent SetCFD · Traditional | 01/24/1986SE |
| K855185 | Glucose Reagent SetCGE · Traditional | 01/22/1986SE |
| K855157 | Lactic Dehydrogenase (VV) Reagent SetCFJ · Traditional | 01/21/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | 01/14/1986SE |
| K855194 | Glucose Oxidase Reagent SetCGA · Traditional | 01/14/1986SE |
Questions and answers
When was Glutamic Oxaloacetic Transaminase Reagent Set cleared by the FDA?
Glutamic Oxaloacetic Transaminase Reagent Set (K855189) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 19 days after the submission was received.
What is the product code of K855189?
The FDA product code is CIQ – Diazo, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.