FDA.reportPublic FDA data

510(k) K963833

Device
Imx Free Triiodothyronine (free T3)
Applicant
ABBOTT LABORATORIES
510(k) number
K963833
Product code
CDP
Decision
Substantially Equivalent (SESE)
Decision date
1996-10-30
Date received
1996-09-24
Regulation
862.1710
Classification name
Radioimmunoassay, Total Triiodothyronine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LAURA L GRANITZ
Address
Dept. 389, Ap30 200 Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CDP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.2000-10-05
K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.1999-06-18
K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.1999-06-02
K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.1999-05-11
K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.1998-12-22
K983434ABBOTT ARCHITECT TOTAL T3Abbott Laboratories1998-11-20
K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories1998-11-20
K974027AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACKAlfa Biotech (Uk) , Ltd.1998-02-02
K974634IMMULITE FREE T3Diagnostic Products Corp.1998-01-02
K973966ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.1997-10-31
K971779TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIAMonobind1997-06-16
K971270DSL ACTIVE T3 EIADiagnostic Systems Laboratories, Inc.1997-05-22
K965058NICHOLS ADVANTAGE CHEMILUMINESCENCE FREE T3 KITNichols Institute Diagnostics1997-03-11
K970016VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)Johnson & Johnson Clinical Diagnostics, Inc.1997-01-30
K963127ELECSYS FT3Boehringer Mannheim Corp.1996-12-16