CDX — Radioimmunoassay, Total Thyroxine Class II
FDA product code CDX covers "Radioimmunoassay, Total Thyroxine", a Class II medical device regulated under 21 CFR 862.1700. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |