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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis Device
510(k) Number K012805
FOIA Releasable 510(k) K012805
Device Name AUTOMARQER
Applicant
Hamilton Thorne Research
100 Cummings Center
Suite 102-C
Beverly,  MA  01915
Applicant Contact DIARMAID DOUGLAS-HAMITON
Correspondent
Hamilton Thorne Research
100 Cummings Center
Suite 102-C
Beverly,  MA  01915
Correspondent Contact DIARMAID DOUGLAS-HAMITON
Regulation Number864.5220
Classification Product Code
POV  
Date Received08/21/2001
Decision Date 03/13/2002
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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