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 Mar 06, 1996
ACTIVE T3 RIA
K960550
Diagnostic Systems Laboratories, Inc.
Chemistry · 27d
Cleared Jan 24, 1996
TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS
K952557
Sigma Diagnostics, Inc.
Chemistry · 236d
Cleared Jan 24, 1996
ACCESS TOTAL T3 ASSAY (MODIFICATION)
K955435
Bio-Rad Laboratories, Inc.
Chemistry · 114d
Cleared Aug 24, 1995
OPUS T3
K953160
Behring Diagnostics, Inc.
Chemistry · 48d
Cleared Dec 09, 1994
IMX T3 ASSAY
K944808
Organon Teknika Corp.
Chemistry · 71d
Cleared Sep 07, 1994
ACCESS(R) TOTAL T3
K940833
Bio-Rad Laboratories, Inc.
Chemistry · 196d
Cleared Jul 14, 1994
AIA-PACK TT3 ASSAY
K936229
Tosoh Medics, Inc.
Toxicology · 197d
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 Feb 25, 1993
TRIODOTHYRONINE (TC) COATED TUBE RIA
K926345
Monobind
Chemistry · 70d
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 May 01, 1991
SRI T3 IMMOENZYMETRIC ASSAY
K910737
Serono-Baker Diagnostics, Inc.
Chemistry · 69d
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 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