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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 K962864
Device Name THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
Applicant
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Applicant Contact JANET A MCGRATH
Correspondent
Alko Diagnostic Corp.
333 Fiske St.
Holliston,  MA  01746
Correspondent Contact JANET A MCGRATH
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received07/23/1996
Decision Date 12/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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