FDA 510(k) Application Details - K861773

Device Classification Name Seminal Fluid, Antigen, Antiserum, Control

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510(K) Number K861773
Device Name Seminal Fluid, Antigen, Antiserum, Control
Applicant ZYGOTEK SYSTEMS, INC.
130 MAPLE ST., SUITE 232
SPRINGFIELD, MA US
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Contact RICHARD B DARDAS
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Regulation Number 866.5800

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Classification Product Code DGB
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Date Received 05/07/1986
Decision Date 07/07/1986
Decision SE - Substantially Equivalent
Classification Advisory Committee PA - Pathology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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