Product Code: CKC
FDA class 1
21 CFR 862.1030
Vanillin Pyruvate, Alt/Sgpt
Clinical Chemistry
The Vanillin Pyruvate, ALT/SGPT test system (product code CKC) is an in-vitro diagnostic device used in clinical chemistry to measure alanine aminotransferase (ALT/SGPT) activity in serum using a vanillin pyruvate colorimetric method, supporting the diagnosis of hepatocellular damage and liver disease. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1030 in the Clinical Chemistry medical specialty.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
5
Basic Information
- Product Code
- CKC
- Device Class
- FDA class 1
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.