← Product Code [CFE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE) · K970477

# HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT (K970477)

_Sebia · CFE · Mar 10, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K970477

## Device Facts

- **Applicant:** Sebia
- **Product Code:** [CFE](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE.md)
- **Decision Date:** Mar 10, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1445
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.

## 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/CFE/K970477](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CFE/K970477)

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