FDA Product Code
FDA Product Code CEE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1685
510(k) Clearances — 25 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K952284 | AMERLITE TBG ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-26 | Traditional | PDF ↗ |
| K930010 | ACCESS THYROID UPTAKE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K910677 | IMMULITE(TM) T-UPTAKE | Cirrus Diagnostics, Inc. | 1991-04-29 | Traditional | PDF ↗ |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1991-01-30 | Traditional | PDF ↗ |
| K900240 | DELFIA TBG KIT | Pharmacia, Inc. | 1990-03-30 | Traditional | PDF ↗ |
| K896991 | ENZYMUN TEST(R) TBK | Boehringer Mannheim Corp. | 1990-03-01 | Traditional | PDF ↗ |
| K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | Amersham Corp. | 1989-08-15 | Traditional | PDF ↗ |
| K885034 | T-UPTAKE MICROASSAY | Diamedix Corp. | 1989-02-02 | Traditional | PDF ↗ |
| K884201 | FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1988-12-14 | Traditional | PDF ↗ |
| K874658 | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | Technicon Instruments Corp. | 1987-12-18 | Traditional | PDF ↗ |
| K862109 | ENZYMUN TEST TBG | Boehringer Mannheim Corp. | 1986-06-30 | Traditional | PDF ↗ |
| K861735 | TIPSEP-TBG ASSAY | Nuclear Diagnostics, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K842167 | TBG RIA | Syncor Intl. Corp. | 1984-07-09 | Traditional | PDF ↗ |
| K842010 | THYROXINE-BINDING GLOBULIN RADIOUMMU | Nichols Institute Diagnostics | 1984-06-25 | Traditional | PDF ↗ |
| K841024 | VENTREZYME T4U IMMUNOASSAY T4U | Ventrex Laboratories, Inc. | 1984-05-09 | Traditional | PDF ↗ |
| K822684 | ENDAB THYROID UPTAKE | Immunotech Corp. | 1982-10-08 | Traditional | PDF ↗ |
| K820252 | TBG DIAGNOSTIC KIT | Diagnostic Reagents, Inc. | 1982-05-05 | Traditional | PDF ↗ |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K800204 | RIA PHASE TBG | Boehringer Mannheim Corp. | 1980-03-19 | Traditional | PDF ↗ |
| K781225 | GLOBULIN TEST, HUMAN THYROXINE BINDING | Hyland Therapeutic Div., Travenol Laboratories | 1978-08-31 | Traditional | PDF ↗ |
| K780671 | 125 I-T3 UPTAKE REAGENT | Radioimmunoassay, Inc. | 1978-06-06 | Traditional | PDF ↗ |
| K780486 | STIKSEP-T3 KIT | Nuclear Diagnostics, Inc. | 1978-04-28 | Traditional | PDF ↗ |
| K772183 | THYROID BINDING GLOBULIN | Corning Medical & Scientific | 1977-12-20 | Traditional | PDF ↗ |
| K771341 | SPINSEP-TBG | Nuclear Diagnostics, Inc. | 1977-08-10 | Traditional | PDF ↗ |
| K760134 | PROCEDURE, RA, THYROXINE BINDING PROTEIN | Bio-Rad | 1976-07-20 | Traditional | PDF ↗ |
Product code CEE · Class II · Clinical Chemistry. Data: openFDA.