Diazo, Ast/Sgot
The Diazo, AST/SGOT test system (product code CIQ) is an in-vitro diagnostic device used in clinical chemistry to measure aspartate aminotransferase (AST/SGOT) enzyme activity in serum using a diazo colorimetric reaction, supporting assessment of liver, cardiac, and muscle pathology. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1100 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CIQ
- Device Class
- FDA class 2
- Regulation Number
- 862.1100
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Jun 07, 1988 | Substantially Equivalent | Tech-Co, Inc. |
| K860216 | SGOT (AST) REAGENT SET | Apr 03, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K855189 | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | Jan 14, 1986 | Substantially Equivalent | Technostics Intl. |
| K844322 | SGOT REAGENT SET | Nov 27, 1984 | Substantially Equivalent | Livonia Diagnostics, Inc. |
| K841065 | SGOT REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K821209 | SGOT REAGENT SET | Jul 14, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K820466 | SGOT REAGENT SET | Mar 11, 1982 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.