← Product Code [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP) · K964310

# VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) (K964310)

_Johnson & Johnson Clinical Diagnostics, Inc. · CDP · Nov 27, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K964310

## Device Facts

- **Applicant:** Johnson & Johnson Clinical Diagnostics, Inc.
- **Product Code:** [CDP](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP.md)
- **Decision Date:** Nov 27, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1710
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K964310](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K964310)

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