CDX · Radioimmunoassay, Total Thyroxine
Clinical Chemistry · 21 CFR 862.1700 · Class 2
Overview
| Product Code | CDX |
|---|---|
| Device Name | Radioimmunoassay, Total Thyroxine |
| Regulation | 21 CFR 862.1700 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (20 of 121)
Showing 20 most recent of 121 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K961490 | ELECSYS T4 ASSAY | Boehringer Mannheim Corp. | Jun 13, 1996 | SESE |
| K954312 | ACTIVE THYROXINE RIA | Diagnostic Systems Laboratories, Inc. | Oct 7, 1995 | SESE |
| K943416 | DELFIA NEONATAL THYROXINE KIT | Wallac OY | Mar 10, 1995 | SESE |
| K934384 | AXSYM(TM) TOTAL T4 | Abbott Laboratories | Jun 21, 1994 | SESE |
| K932980 | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | Sigma Diagnostics, Inc. | Oct 18, 1993 | SESE |
| K933426 | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | Baxter Diagnostics, Inc. | Aug 26, 1993 | SESE |
| K931295 | IQ TT4 ASSAY | Becton Dickinson Advanced Diagnostics | Jul 20, 1993 | SESE |
| K926563 | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | Bio-Chem Laboratory Systems, Inc. | Mar 18, 1993 | SESE |
| K925110 | ABBOTT IMX T4 | Abbott Laboratories | Jan 26, 1993 | SESE |
| K925109 | ABBOTT TDX/TDXFLX TT4 | Abbott Laboratories | Jan 4, 1993 | SESE |
| K922945 | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | Heraeus Kulzer, Inc. | Oct 14, 1992 | SESE |
| K921935 | THYROXINE (T4) COATED TUBE RIA | Monobind | Jul 7, 1992 | SESE |
| K920766 | T4 EIA BEAD ASSAY | Tech-Co, Inc. | Apr 17, 1992 | SESE |
| K915235 | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | Incstar Corp. | Jan 28, 1992 | SESE |
| K912541 | MILENIA TOTAL T4, CATALOG: MKT41,5 | Diagnostic Products Corp. | Aug 12, 1991 | SESE |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | London Diagnostics, Inc. | Aug 2, 1991 | SESE |
| K904816 | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 17, 1991 | SESE |
| K905532 | CIBA CORNING ACS T4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | Jan 15, 1991 | SESE |
| K902922 | MICROZYME T4 ENZYME IMMUNOASSAY KIT | Immunotech Corp. | Jul 27, 1990 | SESE |
| K901475 | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 | Baxter Healthcare Corp | Jun 20, 1990 | SESE |
Top Applicants
- Abbott Laboratories — 6 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 6 clearances
- Bio-Rad — 4 clearances
- Diagnostic Products Corp. — 4 clearances
- Micromedic Systems — 4 clearances
