Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1710](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1710) → CDP — Radioimmunoassay, Total Triiodothyronine # CDP · Radioimmunoassay, Total Triiodothyronine _Clinical Chemistry · 21 CFR 862.1710 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP ## Overview - **Product Code:** CDP - **Device Name:** Radioimmunoassay, Total Triiodothyronine - **Regulation:** [21 CFR 862.1710](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1710) - **Device Class:** 2 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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. ## Classification Rationale Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## Recent Cleared Devices (20 of 144) Showing 20 most recent of 144 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K001607](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K001607.md) | REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104) | Repromedix Corp. | Oct 5, 2000 | SESE | | [K991692](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K991692.md) | CHIRON DIAGNOSTICS ACS: 180 FT3 | Chiron Diagnostics Corp. | Jun 18, 1999 | SESE | | [K991311](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K991311.md) | TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005 | Biocheck, Inc. | Jun 2, 1999 | SESE | | [K991252](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K991252.md) | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | May 11, 1999 | SESE | | [K981824](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K981824.md) | OPTICOAT T3 EIA KIT | Biotecx Laboratories, Inc. | Dec 22, 1998 | SESE | | [K983439](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K983439.md) | ABBOTT ARCHITECT FREE T3 | Abbott Laboratories | Nov 20, 1998 | SESE | | [K983434](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K983434.md) | ABBOTT ARCHITECT TOTAL T3 | Abbott Laboratories | Nov 20, 1998 | SESE | | [K974027](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K974027.md) | AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK | Alfa Biotech (Uk) , Ltd. | Feb 2, 1998 | SESE | | [K974634](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K974634.md) | IMMULITE FREE T3 | Diagnostic Products Corp. | Jan 2, 1998 | SESE | | [K973966](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K973966.md) | ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER | Beckman Instruments, Inc. | Oct 31, 1997 | SESE | | [K971779](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K971779.md) | TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA | Monobind | Jun 16, 1997 | SESE | | [K971270](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K971270.md) | DSL ACTIVE T3 EIA | Diagnostic Systems Laboratories, Inc. | May 22, 1997 | SESE | | [K965058](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K965058.md) | NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT | Nichols Institute Diagnostics | Mar 11, 1997 | SESE | | [K970016](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K970016.md) | VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020) | Johnson & Johnson Clinical Diagnostics, Inc. | Jan 30, 1997 | SESE | | [K963127](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K963127.md) | ELECSYS FT3 | Boehringer Mannheim Corp. | Dec 16, 1996 | SESE | | [K962760](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K962760.md) | ENZYMUN-TEST FT3 | Boehringer Mannheim Corp. | Nov 29, 1996 | SESE | | [K964310](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K964310.md) | VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010) | Johnson & Johnson Clinical Diagnostics, Inc. | Nov 27, 1996 | SESE | | [K963687](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K963687.md) | AIA-PACK FT3 ASSAY | Tosoh Medics, Inc. | Nov 8, 1996 | SESE | | [K963833](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K963833.md) | IMX FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | Oct 30, 1996 | SESE | | [K963827](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP/K963827.md) | AXSYM FREE TRIIODOTHYRONINE (FREE T3) | Abbott Laboratories | Oct 30, 1996 | SESE | ## Top Applicants - Abbott Laboratories — 13 clearances - Amersham Corp. — 7 clearances - Diagnostic Products Corp. — 6 clearances - Boehringer Mannheim Corp. — 4 clearances - Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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