CEE — Radioimmunoassay, Thyroxine-Binding Globulin Class II
FDA Device Classification
Classification Details
- Product Code
- CEE
- Device Class
- Class II
- Regulation Number
- 862.1685
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K952284 | johnson and johnson clinical diagnostics | AMERLITE TBG ASSAY | July 26, 1995 |
| K930010 | bio-rad laboratories | ACCESS THYROID UPTAKE ASSAY | June 7, 1993 |
| K910677 | cirrus diagnostics | IMMULITE(TM) T-UPTAKE | April 29, 1991 |
| K905777 | immunotech | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | January 30, 1991 |
| K900240 | pharmacia | DELFIA TBG KIT | March 30, 1990 |
| K896991 | boehringer mannheim | ENZYMUN TEST(R) TBK | March 1, 1990 |
| K893469 | amersham | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | August 15, 1989 |
| K885034 | diamedix | T-UPTAKE MICROASSAY | February 2, 1989 |
| K884201 | cyberfluor | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | December 14, 1988 |
| K874658 | technicon instruments | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | December 18, 1987 |
| K862109 | boehringer mannheim | ENZYMUN TEST TBG | June 30, 1986 |
| K861735 | nuclear diagnostics | TIPSEP-TBG ASSAY | June 13, 1986 |
| K842167 | syncor intl | TBG RIA | July 9, 1984 |
| K842010 | nichols institute diagnostics | THYROXINE-BINDING GLOBULIN RADIOUMMU | June 25, 1984 |
| K841024 | ventrex laboratories | VENTREZYME T4U IMMUNOASSAY T4U | May 9, 1984 |
| K822684 | immunotech | ENDAB THYROID UPTAKE | October 8, 1982 |
| K820252 | diagnostic reagents | TBG DIAGNOSTIC KIT | May 5, 1982 |
| K810967 | clinical assays | IN-VITRO TBG RADIOIMMUNOASSAY TEST | April 23, 1981 |
| K800204 | boehringer mannheim | RIA PHASE TBG | March 19, 1980 |
| K781225 | hyland therapeutic div., travenol laboratories | GLOBULIN TEST, HUMAN THYROXINE BINDING | August 31, 1978 |