CDX — Radioimmunoassay, Total Thyroxine Class II
FDA Device Classification
Classification Details
- Product Code
- CDX
- Device Class
- Class II
- Regulation Number
- 862.1700
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K961490 | boehringer mannheim | ELECSYS T4 ASSAY | June 13, 1996 |
| K954312 | diagnostic systems laboratories | ACTIVE THYROXINE RIA | October 7, 1995 |
| K943416 | wallac | DELFIA NEONATAL THYROXINE KIT | March 10, 1995 |
| K934384 | abbott laboratories | AXSYM(TM) TOTAL T4 | June 21, 1994 |
| K932980 | sigma diagnostics | TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 | October 18, 1993 |
| K933426 | baxter diagnostics | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO | August 26, 1993 |
| K931295 | becton dickinson advanced diagnostics | IQ TT4 ASSAY | July 20, 1993 |
| K926563 | bio-chem laboratory systems | AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT | March 18, 1993 |
| K925110 | abbott laboratories | ABBOTT IMX T4 | January 26, 1993 |
| K925109 | abbott laboratories | ABBOTT TDX/TDXFLX TT4 | January 4, 1993 |
| K922945 | heraeus kulzer | TECHNICON DAX SYSTEM THYROXINE (T4) METHOD | October 14, 1992 |
| K921935 | monobind | THYROXINE (T4) COATED TUBE RIA | July 7, 1992 |
| K920766 | tech-co | T4 EIA BEAD ASSAY | April 17, 1992 |
| K915235 | incstar | CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT | January 28, 1992 |
| K912541 | diagnostic products | MILENIA TOTAL T4, CATALOG: MKT41,5 | August 12, 1991 |
| K911985 | london diagnostics | LUMATAG T4 CHEMILUMINESCENCE ASSAY | August 2, 1991 |
| K904816 | bd becton dickinson vacutainer systems preanalytic | THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM | January 17, 1991 |
| K905532 | ciba corning diagnostics | CIBA CORNING ACS T4 IMMUNOASSAY | January 15, 1991 |
| K902922 | immunotech | MICROZYME T4 ENZYME IMMUNOASSAY KIT | July 27, 1990 |
| K901475 | baxter healthcare | CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 | June 20, 1990 |