← Product Code [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT) · K790483

# COULTER ACCU-ZYME II GOT REAGENT (K790483)

_Coulter Electronics, Inc. · CIT · May 3, 1979 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K790483

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [CIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT.md)
- **Decision Date:** May 3, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1100
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K790483](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIT/K790483)

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