CEE · Class II · 21 CFR 862.1685

FDA Product Code CEE: Radioimmunoassay, Thyroxine-binding Globulin

Leading manufacturers include Boehringer Mannheim Corp., Immunotech Corp. and Technicon Instruments Corp..

25
Total
25
Cleared
53d
Avg days
1976
Since

FDA 510(k) Cleared Radioimmunoassay, Thyroxine-binding Globulin Devices (Product Code CEE)

25 devices
1–24 of 25
Cleared Jul 26, 1995
AMERLITE TBG ASSAY
K952284
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 71d
Cleared Jun 07, 1993
ACCESS THYROID UPTAKE ASSAY
K930010
Bio-Rad Laboratories, Inc.
Chemistry · 154d
Cleared Jan 30, 1991
MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
K905777
Immunotech Corp.
Immunology · 34d
Cleared Mar 30, 1990
DELFIA TBG KIT
K900240
Pharmacia, Inc.
Chemistry · 72d
Cleared Mar 01, 1990
ENZYMUN TEST(R) TBK
K896991
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared Aug 15, 1989
AMERLITE TBG ASSAY, LAN.0005/1005 240/144 TEST KIT
K893469
Amersham Corp.
Toxicology · 103d
Cleared Feb 02, 1989
T-UPTAKE MICROASSAY
K885034
Diamedix Corp.
Chemistry · 59d
Cleared Dec 18, 1987
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658
Technicon Instruments Corp.
Chemistry · 36d
Cleared Jun 30, 1986
ENZYMUN TEST TBG
K862109
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Jul 09, 1984
TBG RIA
K842167
Syncor Intl. Corp.
Chemistry · 39d
Cleared Jun 25, 1984
THYROXINE-BINDING GLOBULIN RADIOUMMU
K842010
Nichols Institute Diagnostics
Chemistry · 39d
Cleared May 09, 1984
VENTREZYME T4U IMMUNOASSAY T4U
K841024
Ventrex Laboratories, Inc.
Chemistry · 58d
Cleared Oct 08, 1982
ENDAB THYROID UPTAKE
K822684
Immunotech Corp.
Microbiology · 35d
Cleared May 05, 1982
TBG DIAGNOSTIC KIT
K820252
Diagnostic Reagents, Inc.
Chemistry · 96d
Cleared Mar 19, 1980
RIA PHASE TBG
K800204
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Aug 31, 1978
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 44d
Cleared Dec 20, 1977
THYROID BINDING GLOBULIN
K772183
Corning Medical & Scientific
Immunology · 25d
Cleared Jul 20, 1976
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134
Bio-Rad
Chemistry · 22d

About Product Code CEE - Regulatory Context