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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorescence Polarization Immunoassay, Amibacin
510(k) Number K862248
Device Name AMIKACIN KIT (FPIA)
Applicant
Windsor Laboratories, Inc.
P.O. Box 475487
Garland,  TX  75047
Applicant Contact GUY W RUCKER
Correspondent
Windsor Laboratories, Inc.
P.O. Box 475487
Garland,  TX  75047
Correspondent Contact GUY W RUCKER
Regulation Number862.3035
Classification Product Code
LGJ  
Date Received06/12/1986
Decision Date 08/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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