CEE — Radioimmunoassay, Thyroxine-Binding Globulin Class II
FDA product code CEE covers "Radioimmunoassay, Thyroxine-Binding Globulin", a Class II medical device regulated under 21 CFR 862.1685. 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
- 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 |