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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name control, hemoglobin
510(k) Number K964052
Device Name HEMOCUE HEMOTROL
Applicant
DIRECT SOLUTIONS
7 HAYRICK LN.
P.O. BOX 900
WESTFORD,  MA  01886
Applicant Contact BILL DONOHUE
Correspondent
DIRECT SOLUTIONS
7 HAYRICK LN.
P.O. BOX 900
WESTFORD,  MA  01886
Correspondent Contact BILL DONOHUE
Regulation Number864.8625
Classification Product Code
GGM  
Date Received09/30/1996
Decision Date 11/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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