← Product Code [KHQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHQ) · K770033

# SPAC TM T3 UPTAKE KIT (K770033)

_Mallinckrodt Critical Care · KHQ · Feb 7, 1977 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/KHQ/K770033

## Device Facts

- **Applicant:** Mallinckrodt Critical Care
- **Product Code:** [KHQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KHQ.md)
- **Decision Date:** Feb 7, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1715
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/KHQ/K770033](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/KHQ/K770033)

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