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510(k) K946328

Device
Tdx(r)/tdxflx(r) Phenytoin Ii
Applicant
ABBOTT LABORATORIES
510(k) number
K946328
Product code
LGR
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-28
Date received
1994-12-29
Regulation
862.3350
Classification name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DOUG KENTZ
Address
One Abbott Park Rd. D389, Ap30 Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGR#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.1996-03-11
K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.1996-01-24
K953840AXSYM PHENYTOIN IIAbbott Laboratories1995-09-25
K943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.1994-10-27
K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories1994-06-21
K936131COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORSRoche Diagnostic Systems, Inc.1994-03-11
K896868OPUS PHENYTOIN TEST SYSTEMPb Diagnostic Systems, Inc.1990-01-02
K895827INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SETInnotron of Oregon, Inc.1989-10-31
K872563INNOTRON INNOFLUOR PHEYTOIN REAGENT SETInnotron of Oregon, Inc.1987-08-21
K862554IMMPULSE PHENYTOIN ASSAY REAGENTSclavo, Inc.1986-07-16
K843824COBAS FP REAGENTS FOR PHENYTOIN & CALIBRRoche Diagnostic Systems, Inc.1985-02-01
K844171PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTEBd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10
K842586PHENYTOIN KIT FLUORESCENCE POLARIZATIONWindsor Laboratories, Inc.1984-09-26
K841706INNOFLUOR PHENYTOINInnotron Diagnostics1984-05-22