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510(k) K940596

Device
Axsym Phenobarbital
Applicant
ABBOTT LABORATORIES
510(k) number
K940596
Product code
LGQ
Decision
Substantially Equivalent (SESE)
Decision date
1994-06-21
Date received
1994-02-10
Regulation
862.3660
Classification name
Fluorescence Polarization Immunoassay, Phenobarbital
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
KATHY ZENG
Address
Rte. 7, Bond Park Spartanburg SC US 29301 29301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972331INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.1997-08-01
K972330INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.1997-07-14
K936130COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.1994-03-11
K900704MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.1990-04-12
K894525FPR PHENOBARBITAL KITColony Laboratories, Inc.1989-08-28
K872397COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.Roche Diagnostic Systems, Inc.1987-07-21
K863625PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KITWindsor Laboratories, Inc.1986-11-10
K862528IMMPULSE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.1986-07-16
K854044TDX BARBITURATESAbbott Laboratories1985-10-28
K843825COBAS REAGENTS PHENOBARBITAL & PHENOBARRoche Diagnostic Systems, Inc.1985-02-01
K841707INNOFLUOR PHENOBARBITALInnotron Diagnostics1984-05-23