CEE · Class II · 21 CFR 862.1685

FDA Product Code CEE: Radioimmunoassay, Thyroxine-binding Globulin

Leading manufacturers include Boehringer Mannheim Corp., Technicon Instruments Corp. and Bio-Rad.

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 Mar 01, 1990
ENZYMUN TEST(R) TBK
K896991
Boehringer Mannheim Corp.
Chemistry · 78d
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 Mar 19, 1980
RIA PHASE TBG
K800204
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jul 20, 1976
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134
Bio-Rad
Chemistry · 22d

About Product Code CEE - Regulatory Context