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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 K882600
Device Name HEMOCUE HEMOGLOBIN CALIBRATOR
Applicant
React and Co.
1142 Manhattan Ave.
Suite 2
Manhattan Beach,  CA  90266
Applicant Contact ROBERT E ADLER
Correspondent
React and Co.
1142 Manhattan Ave.
Suite 2
Manhattan Beach,  CA  90266
Correspondent Contact ROBERT E ADLER
Regulation Number864.8165
Classification Product Code
KRZ  
Date Received06/24/1988
Decision Date 07/18/1988
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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