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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Equipment, Rocket Immunoelectrophoresis
510(k) Number K930796
Device Name ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS
Applicant
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Applicant Contact BRIAN J YOUNG
Correspondent
Alko Diagnostic Corp.
Alko Park
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact BRIAN J YOUNG
Regulation Number866.4830
Classification Product Code
JZX  
Date Received02/16/1993
Decision Date 01/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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