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
25–48 of 144
Cleared Jun 21, 1994
AXSYM TOTAL T3
K934517
Abbott Laboratories
Toxicology · 274d
Cleared Mar 22, 1994
VIDAS T3 ASSAY
K934764
Biomerieux Vitek, Inc.
Chemistry · 169d
Cleared Dec 03, 1993
COBAS(R) CORE T3 EIA
K932608
Roche Diagnostic Systems, Inc.
Chemistry · 189d
Cleared Dec 03, 1993
CIBA CORNING ACS FREE T3 IMMUNOASSAY
K932747
Ciba Corning Diagnostics Corp.
Chemistry · 178d
Cleared Dec 28, 1992
MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT
K925436
Medix Biotech, Inc.
Chemistry · 61d
Cleared Oct 15, 1992
VISTA TRIIODOTHYRONINE ASSAY
K923571
Syva Co.
Chemistry · 90d
Cleared Oct 14, 1992
KODAK AMERLEX MAB FT3 ASSAY
K922771
Eastman Kodak Company
Chemistry · 127d
Cleared Sep 23, 1992
TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE
K923258
Heraeus Kulzer, Inc.
Chemistry · 83d
Cleared Sep 02, 1992
TOTAL T3 CHEMILUMINESCENCE ASSAY
K923015
Nichols Institute Diagnostics
Chemistry · 72d
Cleared Feb 06, 1992
MILENIA TOTAL T3
K914467
Diagnostic Products Corp.
Chemistry · 122d
Cleared Feb 06, 1992
DOCUMENT CK ISOENZYMES CONTROL
K915792
Casco Standards
Chemistry · 44d
Cleared Feb 04, 1991
OPUS T3 TEST SYSTEM
K905410
Pb Diagnostic Systems, Inc.
Toxicology · 63d
Cleared Jan 23, 1991
IMX FREE TRIIODOTHYRONINE
K905261
Abbott Laboratories
Chemistry · 63d
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 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 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