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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 K963908
Device Name HEMOCUE HEMOLIN
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 10/16/1996
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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