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

FDA 510(k) Cleared Radioimmunoassay, Total Triiodothyronine Devices (Product Code CDP)

144 devices
1–24 of 144
Cleared May 11, 1999
AIA-PACK FT3 ASSAY
K991252
Tosoh Medics, Inc.
Chemistry · 28d
Cleared Nov 20, 1998
ABBOTT ARCHITECT TOTAL T3
K983434
Abbott Laboratories
Chemistry · 52d
Cleared Nov 20, 1998
ABBOTT ARCHITECT FREE T3
K983439
Abbott Laboratories
Chemistry · 52d
Cleared Jan 02, 1998
IMMULITE FREE T3
K974634
Diagnostic Products Corp.
Chemistry · 21d
Cleared Oct 31, 1997
ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K973966
Beckman Instruments, Inc.
Chemistry · 14d
Cleared May 22, 1997
DSL ACTIVE T3 EIA
K971270
Diagnostic Systems Laboratories, Inc.
Chemistry · 48d
Cleared Mar 11, 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KIT
K965058
Nichols Institute Diagnostics
Chemistry · 83d
Cleared Jan 30, 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
K970016
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 16, 1996
ELECSYS FT3
K963127
Boehringer Mannheim Corp.
Chemistry · 126d
Cleared Nov 29, 1996
ENZYMUN-TEST FT3
K962760
Boehringer Mannheim Corp.
Chemistry · 136d
Cleared Nov 27, 1996
VITROS IMMUNODIAGNOSTICS PRODUCT - TOTAL T3 REAGENT PACK (GEM .101) AND TOTAL CALIIBRATION (GEM.C010)
K964310
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 29d
Cleared Nov 08, 1996
AIA-PACK FT3 ASSAY
K963687
Tosoh Medics, Inc.
Chemistry · 53d
Cleared Oct 30, 1996
AXSYM FREE TRIIODOTHYRONINE (FREE T3)
K963827
Abbott Laboratories
Chemistry · 36d
Cleared Oct 30, 1996
IMX FREE TRIIODOTHYRONINE (FREE T3)
K963833
Abbott Laboratories
Chemistry · 36d
Cleared Aug 15, 1996
ELECSYS T3
K962508
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jul 12, 1996
FREE TRIIODOTHYRONINE(FT3) ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
K962355
Bayer Corp.
Chemistry · 24d
Cleared Mar 29, 1996
ACCESS FREE T3 ASSAY
K960913
Bio-Rad Laboratories, Inc.
Chemistry · 23d
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

About Product Code CDP - Regulatory Context