Hydrazone Colorimetry, Ast/Sgot
The Hydrazone Colorimetry, AST/SGOT test system (product code CIS) is an in-vitro diagnostic device used in clinical chemistry to measure aspartate aminotransferase (AST/SGOT) activity in serum using a hydrazone colorimetric method based on the reaction of keto acids with 2,4-dinitrophenylhydrazine. 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
- CIS
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K032027 | CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) | Sep 05, 2003 | Substantially Equivalent | Cholestech Corp. |
| K896238 | COBAS READY AST REAGENT | Feb 16, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K854187 | IN-VITRO TEST DETERMINATION OF SGOT (AST) | Nov 25, 1985 | Substantially Equivalent | Clinical Data, Inc. |
| K812872 | OPTIONAL TOTAL CA-MODULE FOR IL 504/508 | Oct 26, 1981 | Substantially Equivalent | Instrumentation Laboratory CO |
| K792410 | ELVI SGOT & SGPT TRANSAMINASE | Dec 06, 1979 | Substantially Equivalent | Volu Sol Medical Industries |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.