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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 K983473
Device Name FERTILMARQ TEST KIT
Applicant
Embryotech Laboratories, Inc.
323 Andover St.
Wilmington,  MA  01887
Applicant Contact ANN D MCGONIGLE
Correspondent
Embryotech Laboratories, Inc.
323 Andover St.
Wilmington,  MA  01887
Correspondent Contact ANN D MCGONIGLE
Regulation Number864.5220
Classification Product Code
POV  
Date Received10/02/1998
Decision Date 12/17/1998
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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