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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Seminal Fluid, Antigen, Antiserum, Control
510(k) Number K861773
Device Name ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
Applicant
Zygotek Systems, Inc.
130 Maple St., Suite 232
Springfield,  MA  01103
Applicant Contact RICHARD B DARDAS
Correspondent
Zygotek Systems, Inc.
130 Maple St., Suite 232
Springfield,  MA  01103
Correspondent Contact RICHARD B DARDAS
Regulation Number866.5800
Classification Product Code
DGB  
Date Received05/07/1986
Decision Date 07/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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