FDA 510(k) Application Details - K940243

Device Classification Name D/Km-1, Antigen, Antiserum, Control

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510(K) Number K940243
Device Name D/Km-1, Antigen, Antiserum, Control
Applicant VENTANA MEDICAL SYSTEMS, INC.
3865 N. BUSINESS CENTER DR.
TUCSON, AZ US
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Contact KATHLEEN WINDALL
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Regulation Number 866.5065

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Classification Product Code DHF
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Date Received 01/19/1994
Decision Date 09/07/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee HE - Hematology
Review Advisory Committee IM - Immunology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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