Aspartate Aminotransferase (Colorimetric Method)
FDA 510(k) K881173 · Tech-Co, Inc.
510(k) numberK881173
Submission
- Device name
- Aspartate Aminotransferase (Colorimetric Method)
- Applicant
- Tech-Co, Inc.
Oak Park, MI, US - Received
- March 18, 1988
- Decision date
- June 7, 1988
- 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 |
|---|---|---|---|
| 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 |
| K821209 | Sgot Reagent SetCIQ · Traditional | Omega Medical Electronics | 07/14/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
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| K920766 | T4 Eia Bead AssayCDX · Traditional | 04/17/1992SE |
| K920716 | Direct Pregnancy TestJHJ · Traditional | 03/24/1992SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | 07/10/1990SE |
| K901561 | Iron/Total Iron Binding CapacityJIY · Traditional | 05/17/1990SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | 10/13/1988SE |
| K883683 | HemoglobinGJZ · Traditional | 10/06/1988SE |
| K883386 | ChlorideCHJ · Traditional | 10/06/1988SE |
| K881172 | Bilirubin (Direct)CIG · Traditional | 06/07/1988SE |
Questions and answers
When was Aspartate Aminotransferase (Colorimetric Method) cleared by the FDA?
Aspartate Aminotransferase (Colorimetric Method) (K881173) received a 510(k) decision of Substantially Equivalent on June 7, 1988, 81 days after the submission was received.
What is the product code of K881173?
The FDA product code is CIQ – Diazo, Ast/Sgot, a Class II (moderate risk) device regulated under 21 CFR 862.1100.