CDP · Class II · 21 CFR 862.1710

FDA Product Code CDP: Radioimmunoassay, Total Triiodothyronine

Leading manufacturers include Abbott Laboratories, Amersham Corp. and Diagnostic Products Corp..

144
Total
144
Cleared
62d
Avg days
1976
Since
144 devices
49–72 of 144
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261
Abbott Laboratories
Chemistry · 63d
Cleared Jan 23, 1991
FLAGEN TRIIODOTHYRONINE (T3) ASSAY
K905656
Cyberfluor, Inc.
Chemistry · 37d
Cleared Dec 18, 1990
MICROZYME T3 ENZYME IMMUNOASSAY KIT
K904820
Immunotech Corp.
Immunology · 55d
Cleared Oct 12, 1990
TDX FREE T3 CALCULATION
K903433
Abbott Laboratories
Chemistry · 73d
Cleared Sep 27, 1990
CEDIA TOTAL T3 ASSAY
K904098
Microgenics Corp.
Chemistry · 21d
Cleared Sep 07, 1990
IMX FREE T3 CALCULATION
K903432
Abbott Laboratories
Chemistry · 38d
Cleared Mar 09, 1990
TOSOH AIA-PACK T3
K897001
Tosoh Corp.
Chemistry · 81d
Cleared Feb 08, 1990
ENZYMUN TEST R T3
K896900
Boehringer Mannheim Corp.
Chemistry · 62d
Cleared Oct 31, 1989
ABBOTT TDX TOTAL T3 PLUS
K894238
Abbott Laboratories
Chemistry · 132d
Cleared Oct 19, 1989
MILENIA(TM) TOTAL T4 (MKT41,5)
K895840
Diagnostic Products Corp.
Chemistry · 16d
Cleared Oct 13, 1989
STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I.
K894993
Baxter Healthcare Corp
Toxicology · 66d
Cleared Sep 25, 1989
FREE T3 RADIOIMMUNOASSAY KIT
K894200
Advanced Magnetics, Inc.
Chemistry · 101d
Cleared Aug 11, 1989
T3 CLASP-BEAD EIA KIT
K893620
Biotecx Laboratories, Inc.
Chemistry · 92d
Cleared Feb 08, 1989
AMERLITE FT3 ASSAY, LAN.0007/2007 240/144 TEST KIT
K885195
Amersham Corp.
Chemistry · 54d
Cleared Dec 02, 1988
DELFIA TRIIODOTHYRONINE (T3) KIT
K883810
Pharmacia, Inc.
Chemistry · 85d
Cleared Oct 25, 1988
STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME
K883479
Baxter Healthcare Corp
Chemistry · 70d
Cleared May 27, 1988
IMMPULSE T, ASSAY REAGENTS
K881214
Sclavo, Inc.
Toxicology · 67d
Cleared May 27, 1988
AMERLITE TT3 ASSAY, LAN.0003/2003 240/144 KIT
K881373
Amersham Corp.
Chemistry · 56d
Cleared Apr 18, 1988
ABBOTT IMX T3
K880087
Abbott Laboratories
Chemistry · 97d
Cleared Mar 03, 1988
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388
Serono Diagnostics, Inc.
Chemistry · 35d
Cleared Nov 24, 1987
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY
K873737
Cambridge Medical Technology
Chemistry · 70d
Cleared Nov 23, 1987
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY
K873945
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Nov 03, 1987
AMERLITE TT3 ASSAY, LAN.0003/1003/2003
K873858
Amersham Corp.
Chemistry · 42d
Cleared Aug 13, 1987
IMMUBEAD T3 ENZYME IMMUNOASSAY KIT
K872191
Immunotech Corp.
Chemistry · 66d