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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Hemoglobin And Hematocrit Measurement
510(k) Number K951071
Device Name ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS
Applicant
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact BRIAN J YOUNG
Correspondent
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact BRIAN J YOUNG
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received03/08/1995
Decision Date 07/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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