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510(k) K944063

Device
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
Applicant
SIGMA DIAGNOSTICS, INC.
510(k) number
K944063
Product code
LGI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-11-10
Date received
1994-08-19
Regulation
862.3645
Classification name
Fluorescence Polarization Immunoassay, Carbamazepine
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
HOYLE D HILL
Address
545 S. Ewing Ave. St. Louis MO US 63103 63103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LGI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940682AXSYM(TM) QUINIDINEAbbott Laboratories1994-06-21
K900702MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRAInnotron of Oregon, Inc.1990-04-12

Legacy Summary#

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FDA Review#

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