510(k) K884201
- Device
- FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT
- Applicant
- CYBERFLUOR, INC.
- 510(k) number
- K884201
- Product code
- CEE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-14
- Date received
- 1988-10-06
- Regulation
- 862.1685
- Classification name
- Radioimmunoassay, Thyroxine-binding Globulin
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES CLELLAND
- Address
- 179 John St., 4th Floor , Toronto Ontario M5t 1x4 CA
FDA Registration Numbers#
- 3006198300
- 2029372
- 3009984016
- 2020726
- 1036362
- 3002806944
- 2122870
- 3003741796
- 3004192065
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CEE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952284 | AMERLITE TBG ASSAY | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-26 |
| K930010 | ACCESS THYROID UPTAKE ASSAY | Bio-Rad Laboratories, Inc. | 1993-06-07 |
| K910677 | IMMULITE(TM) T-UPTAKE | Cirrus Diagnostics, Inc. | 1991-04-29 |
| K905777 | MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT | Immunotech Corp. | 1991-01-30 |
| K900240 | DELFIA TBG KIT | Pharmacia, Inc. | 1990-03-30 |
| K896991 | ENZYMUN TEST(R) TBK | Boehringer Mannheim Corp. | 1990-03-01 |
| K893469 | AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT | Amersham Corp. | 1989-08-15 |
| K885034 | T-UPTAKE MICROASSAY | Diamedix Corp. | 1989-02-02 |
| K874658 | TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) | Technicon Instruments Corp. | 1987-12-18 |
| K862109 | ENZYMUN TEST TBG | Boehringer Mannheim Corp. | 1986-06-30 |
| K861735 | TIPSEP-TBG ASSAY | Nuclear Diagnostics, Inc. | 1986-06-13 |
| K842167 | TBG RIA | Syncor Intl. Corp. | 1984-07-09 |
| K842010 | THYROXINE-BINDING GLOBULIN RADIOUMMU | Nichols Institute Diagnostics | 1984-06-25 |
| K841024 | VENTREZYME T4U IMMUNOASSAY T4U | Ventrex Laboratories, Inc. | 1984-05-09 |
| K822684 | ENDAB THYROID UPTAKE | Immunotech Corp. | 1982-10-08 |
Legacy Summary#
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FDA Review#
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