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510(k) K862248

Device
AMIKACIN KIT (FPIA)
Applicant
WINDSOR LABORATORIES, INC.
510(k) number
K862248
Product code
LGJ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-04
Date received
1986-06-12
Regulation
862.3035
Classification name
Fluorescence Polarization Immunoassay, Amibacin
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GUY W RUCKER
Address
P.O. Box 475487 Garland TX US 75047 75047

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LGJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K991597COBAS INTEGRA AMIKACIN MABRoche Diagnostics Corp.1999-07-22
K941712COBAS-FP REAGENTS AND CALIBRATORSRoche Diagnostic Systems, Inc.1994-06-13

Legacy Summary#

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FDA Review#

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