← Product Code [CKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKA) · K812926

# ALT-QUANTICHROM (K812926)

_Abbott Laboratories · CKA · Nov 6, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKA/K812926

## Device Facts

- **Applicant:** Abbott Laboratories
- **Product Code:** [CKA](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKA.md)
- **Decision Date:** Nov 6, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1030
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKA/K812926](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CKA/K812926)

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