← Product Code [KLI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLI) · K834102

# RA-1000 SYS-T4(THYROXINE)SERUM ANAL (K834102)

_Technicon Instruments Corp. · KLI · Mar 15, 1984 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLI/K834102

## Device Facts

- **Applicant:** Technicon Instruments Corp.
- **Product Code:** [KLI](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLI.md)
- **Decision Date:** Mar 15, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1700
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

## 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/KLI/K834102](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KLI/K834102)

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