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510(k) K861773

ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM by Zygotek Systems, Inc. — Product Code DGB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1986
Date Received
May 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Seminal Fluid, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5800
Review Panel
HE
Submission Type