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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 K831306
Device Name HEMACAL
Applicant
Hematology Marketing Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hematology Marketing Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received04/22/1983
Decision Date 06/16/1983
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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