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510(k) K934384

Device
Axsym(tm) Total T4
Applicant
ABBOTT LABORATORIES
510(k) number
K934384
Product code
CDX
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-21
Date received
1993-09-01
Regulation
862.1700
Classification name
Radioimmunoassay, Total Thyroxine
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
JOY C SONSALLA
Address
Dept: 09v8 Bldg: Ap5-2 100 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 CDX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.1996-06-13
K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.1995-10-07
K943416DELFIA NEONATAL THYROXINE KITWallac OY1995-03-10
K932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.1993-10-18
K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.1993-08-26
K931295IQ TT4 ASSAYBecton Dickinson Advanced Diagnostics1993-07-20
K926563AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KITBio-Chem Laboratory Systems, Inc.1993-03-18
K925110ABBOTT IMX T4Abbott Laboratories1993-01-26
K925109ABBOTT TDX/TDXFLX TT4Abbott Laboratories1993-01-04
K922945TECHNICON DAX SYSTEM THYROXINE (T4) METHODHeraeus Kulzer, Inc.1992-10-14
K921935THYROXINE (T4) COATED TUBE RIAMonobind1992-07-07
K920766T4 EIA BEAD ASSAYTech-Co, Inc.1992-04-17
K915235CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KITIncstar Corp.1992-01-28
K912541MILENIA TOTAL T4, CATALOG: MKT41,5Diagnostic Products Corp.1991-08-12
K911985LUMATAG T4 CHEMILUMINESCENCE ASSAYLondon Diagnostics, Inc.1991-08-02